Note: 1 mcg = 40 units
Osteoporosis, prevention (off-label use): Adults ≥50 years of age: Oral: 800 to 1,000 units/day (20 to 25 mcg/day) is recommended, through dietary sources and/or supplementation if needed (NOF [Cosman 2014]).
Vitamin D insufficiency/deficiency (off-label use):
Note: The optimal serum 25-hydroxyvitamin D (25[OH]D) level has not been established; generally, deficiency is defined as 25(OH)D levels <12 ng/mL (<30 nmol/L), and insufficiency is defined as 25(OH)D levels 12 to <20 ng/mL (30 to <50 nmol/L) (Giustina 2019). Therefore, some experts suggest a target range of 20 to 40 ng/mL (50 to 100 nmol/L) for most patients (Dawson-Hughes 2022). Individualize dose based on patient-specific factors (eg, presence of malabsorption, liver disease, kidney disease) and target 25(OH)D level and ensure adequate calcium intake during therapy (Dawson-Hughes 2022; NOF [Cosman 2014]). The following recommendations are based primarily on expert opinion and clinical experience:
Prevention:
Oral: 600 to 1,000 units (15 to 25 mcg) once daily (IOM 2011; NOF [Cosman 2014]).
Treatment:
Initial dosing:
High-dose therapy: May be preferred in patients with a serum 25(OH)D level <12 ng/mL (<30 nmol/L) or who are symptomatic (eg, bone fracture/pain, muscle weakness), or in patients with concomitant hypocalcemia (Dawson-Hughes 2022; Goltzman 2022; NOF [Cosman 2014]).
Oral: 50,000 units (1,250 mcg) once weekly (or equivalent dose administered once daily) for 6 to 12 weeks, then recheck 25(OH)D level; may repeat high-dose therapy if needed to achieve target 25(OH)D level (Dawson-Hughes 2022; Goltzman 2022; NOF [Cosman 2014]).
Low-dose therapy: May be preferred in patients with a serum 25(OH)D level 12 to <20 ng/mL (30 to <50 nmol/L) without symptoms or concomitant hypocalcemia (Dawson-Hughes 2022).
Oral: 800 to 1,000 units (20 to 25 mcg) once daily for ~3 to 4 months; may adjust dose if needed every 3 to 4 months based on 25(OH)D level. Some experts suggest modest dose increases (eg, to 2,000 units [50 mcg] once daily) if serum 25(OH)D levels have substantially increased but remain below target or switching to high-dose therapy if serum 25(OH)D levels remain substantially below target (Dawson-Hughes 2022).
Maintenance dosing: Oral: Once target 25(OH)D level is achieved, continue at a maintenance dose of 600 to 2,000 units (15 to 50 mcg) once daily (Dawson-Hughes 2022; NOF [Cosman 2014]).
Special populations (eg, obesity, patients on medications known to affect vitamin D metabolism, malabsorption, gastrectomy): Higher doses or longer durations may be necessary for adequate replacement. In patients with malabsorption when target 25(OH)D levels cannot be maintained with cholecalciferol, consider switching to hydroxylated vitamin D metabolites (eg, calcitriol) (Brandi 2013; Dawson-Hughes 2022).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling
In patients with chronic kidney disease (CKD) G3a to G5D, Kidney Disease: Improving Global Outcomes guidelines recommend correcting vitamin D deficiency and insufficiency with treatment strategies recommended for patients without kidney impairment. In patients with CKD G4 to G5 with severe and progressive hyperparathyroidism despite correction of modifiable factors (eg, hyperphosphatemia, vitamin D deficiency), calcitriol or vitamin D analogs are suggested (KDIGO 2017).
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Vitamin D3 (cholecalciferol): Pediatric drug information")
Note: 1 mcg = 40 units.
Vitamin D deficiency, prevention (eg, Rickets prevention): (AAP [Golden 2014]; Abrams 2020; Munns 2016):
Breastfed infants (fully or partially): Oral: 400 units (10 mcg) daily beginning in the first few days of life; continue supplementation unless infant is transitioned to full formula intake.
Children and Adolescents without adequate intake: Oral: 600 units (15 mcg) daily. Note: Children with increased risk of vitamin D deficiency (chronic fat malabsorption, maintained on chronic antiseizure medications) may require higher doses; use laboratory testing [25(OH)D, PTH, bone mineral status] to evaluate.
Vitamin D deficiency (severe, symptomatic), treatment: Note: Treatment should also include calcium supplementation; some patients with chronic fat malabsorption, obesity, or who are maintained on chronic antiseizure medications, glucocorticoids, HIV medications, or antifungals may require higher doses of cholecalciferol (AAP [Golden 2014]); monitor vitamin D status closely.
Infants: Oral: 2,000 units (50 mcg) daily for 6 weeks to achieve a serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 400 to 1,000 units (10 to 25 mcg) daily. Note: For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014]).
Children and Adolescents: Oral: 2,000 units (50 mcg) daily for 6 to 8 weeks to achieve serum 25(OH)D level >20 ng/mL; followed by a maintenance dose of 600 to 1,000 units (15 to 25 mcg) daily. Note: For patients at high risk of fractures a serum 25(OH)D level >30 ng/mL has been suggested (AAP [Golden 2014]).
Vitamin D deficiency in cystic fibrosis, prevention and treatment:
CF guidelines (CF Foundation [Tangpricha 2012]):
Recommended initial daily intake to maintain serum 25(OH)D level ≥30 ng/mL:
Infants: Oral: 400 to 500 units (10 to 12.5 mcg) once daily.
Children ≤10 years: Oral: 800 to 1,000 units (20 to 25 mcg) once daily.
Children >10 years and Adolescents: Oral: 800 to 2,000 units (20 to 50 mcg) once daily.
Dosing adjustment for serum 25(OH)D level between 20 to 30 ng/mL and patient adherence established (Step 1 increase):
Infants: Oral: 800 to 1,000 units (20 to 25 mcg) once daily.
Children ≤10 years: Oral: 1,600 to 3,000 units (40 to 75 mcg) once daily.
Children >10 years and Adolescents: Oral: 1,600 to 6,000 units (40 to 150 mcg) once daily.
Dosing adjustment for serum 25(OH)D level <20 ng/mL or persistently between 20 to 30 ng/mL and patient adherence established (Step 2 increase):
Infants: Oral: Increase up to a maximum 2,000 units (50 mcg) once daily.
Children ≤10 years: Oral: Increase to a maximum of 4,000 units (100 mcg) once daily.
Children >10 years and Adolescents: Oral: Increase to a maximum of 10,000 units (250 mcg) once daily.
Alternate dosing (Hall 2010):
Initial dose: Serum 25(OH)D level ≤30 ng/mL.
Infants: Oral: 8,000 units (200 mcg) once weekly.
Children and Adolescents: Oral: 800 units (20 mcg) once daily.
Medium-dose regimen: Serum 25(OH)D level remains ≤30 ng/mL and patient compliance established.
Infants and Children <5 years: Oral: 12,000 units (300 mcg) once weekly for 12 weeks.
Children ≥5 years and Adolescents: Oral: 50,000 units (1,250 mcg) once weekly for 12 weeks.
High-dose regimen: Repeat 25(OH)D level remains ≤30 ng/mL and patient compliance established.
Infants and Children <5 years: Oral: 12,000 units (300 mcg) twice weekly for 12 weeks.
Children ≥5 years and Adolescents: Oral: 50,000 units (1,250 mcg) twice weekly for 12 weeks.
Vitamin D insufficiency or deficiency associated with CKD (stages 2 to 5, 5D), treatment; serum 25 hydroxyvitamin D [25(OH)D] level ≤30 ng/mL (KDOQI Guidelines 2009):
Serum 25(OH)D level 16 to 30 ng/mL: Infants, Children, and Adolescents: Oral: 2,000 units (50 mcg) daily for 3 months or 50,000 units (1,250 mcg) every month for 3 months.
Serum 25(OH)D level 5 to 15 ng/mL: Infants, Children, and Adolescents: Oral: 4,000 units (100 mcg) daily for 12 weeks or 50,000 units (1,250 mcg) every other week for 12 weeks.
Serum 25(OH)D level <5 ng/mL: Infants, Children, and Adolescents: Oral: 8,000 units (200 mcg) daily for 4 weeks then 4,000 units (100 mcg) daily for 2 months for total therapy of 3 months or 50,000 units (1,250 mcg) weekly for 4 weeks followed by 50,000 units (1,250 mcg) 2 times/month for a total therapy of 3 months.
Maintenance dose [once repletion accomplished; serum 25(OH)D level >30 ng/mL]: Infants, Children, and Adolescents: Oral: 200 to 1,000 units (5 to 25 mcg) daily.
Nutritional rickets, treatment: Limited data available (Munns 2016): Administer in combination with calcium supplementation:
Daily therapy (preferred):
Infants: Oral: 2,000 units (50 mcg) daily for ≥3 months, followed by maintenance dose of 400 units (10 mcg) daily.
Children: Oral: 3,000 to 6,000 units (75 to 150 mcg) daily for ≥3 months, followed by maintenance dose of 600 units (15 mcg) daily.
Adolescents: Oral: 6,000 units (150 mcg) daily for ≥3 months, followed by maintenance dose of 600 units (15 mcg) daily.
Single-dose therapy:
Infants ≥3 months: Oral: 50,000 units (1,250 mcg) once, or in divided doses over several days; after 3 months, initiate maintenance dose of 400 units (10 mcg) daily.
Children: Oral: 150,000 units (3,750 mcg) once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units (15 mcg) daily.
Adolescents: Oral: 300,000 units (7,500 mcg) once, or in divided doses over several days; after 3 months, initiate maintenance dose of 600 units (15 mcg) daily.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, cholecalciferol is not renally eliminated to a significant extent and dosage adjustment is not necessary.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
D3-50: 1250 mcg (50000 unit) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]
Decara: 1250 mcg (50000 unit) [contains fd&c yellow #6 (sunset yellow), quinoline yellow (d&c yellow #10), soybean oil]
Decara: 250 mcg (10000 unit) [DSC] [contains fd&c yellow #6(sunset yellow)alumin lake, gelatin (bovine), quinoline (d&c yellow #10) aluminum lake]
Decara: 625 mcg (25000 unit) [contains soybean oil]
Dialyvite Vitamin D 5000: 125 mcg (5000 unit)
Pronutrients Vitamin D3: 25 mcg (1000 unit) [contains soybean oil]
Weekly-D: 1250 mcg (50000 unit) [contains fd&c red #40 (allura red ac dye)]
Generic: 1250 mcg (50000 unit), 250 mcg (10000 unit), 50 mcg (2000 unit)
Capsule, Oral [preservative free]:
D-3-5: 125 mcg (5000 unit) [dairy free, dye free, egg free, gluten free, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]
D3-50: 1250 mcg (50000 unit) [dairy free, egg free, fish derivative free, gluten free, kosher certified, no artificial color(s), nut free, soy free, sugar free, wheat free, yeast free]
Generic: 10,000 units, 125 mcg (5000 unit), 25 mcg (1000 unit), 50 mcg (2000 unit)
Liquid, Oral:
Aqueous Vitamin D: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar free; contains corn oil, methylparaben, polysorbate 80]
BProtected Pedia D-Vite: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, sugar free; contains polysorbate 80, propylene glycol, sodium benzoate; cherry flavor]
D-Vi-Sol: 10 mcg/mL (400 unit/mL) (50 mL) [gluten free, lactose free, sugar free; contains polysorbate 80]
D-Vite Pediatric: 10 mcg/mL (400 unit/mL) (50 mL) [alcohol free, gluten free, lactose free, no artificial color(s), sugar free; contains disodium edta, polysorbate 80, propylene glycol, saccharin sodium, sodium benzoate]
D3 Vitamin: 10 mcg/mL (400 unit/mL) (50 mL [DSC]) [contains polysorbate 80, sodium benzoate]
Osteo-Vit3: 417 mcg/mL (15 mL)
Generic: 10 mcg/mL (400 unit/mL) (50 mL, 52 mL)
Liquid, Oral [preservative free]:
Generic: 125 mcg/mL (5000 unit/mL) (52 mL)
Liquid, Sublingual:
Generic: 125 mcg/mL (5000 units/mL) (60 mL)
Tablet, Oral:
Delta D3: 10 mcg (400 unit) [gelatin free, gluten free, lactose free, no artificial color(s), no artificial flavor(s), starch free, sugar free, yeast free]
Dialyvite 5000: 5 mg
Dialyvite Vitamin D3 Max: 1250 mcg (50000 unit) [scored]
Vitamin D3 Ultra Potency: 1250 mcg (50000 unit)
Generic: 10 mcg (400 unit), 125 mcg (5000 unit), 20 mcg (800 unit), 25 mcg (1000 unit), 250 mcg (10000 unit), 50 mcg (2000 unit), 75 mcg (3000 unit)
Tablet, Oral [preservative free]:
Generic: 5000 units, 10 mcg (400 unit), 25 mcg (1000 unit), 50 mcg (2000 unit)
Tablet Chewable, Oral:
VitaChew Vitamin D3: 25 mcg (1000 unit) [dairy free, gluten free, no artificial color(s), no artificial flavor(s), nut free, soy free; contains coconut oil (copra/cocos nucifera oil)]
Generic: 10 mcg (400 unit)
Tablet Chewable, Oral [preservative free]:
Generic: 50 mcg (2000 unit)
Yes
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 1250 mcg (50000 unit), 250 mcg (10000 unit), 50 mcg (2000 unit)
Tablet, Oral:
Generic: 250 mcg (10000 unit)
Oral: Wafers: Chew or crush before swallowing; do not swallow wafer whole; administer with the largest meal of the day.
Oral: May be administered without regard to meals; for oral liquid, administer with an accurate measuring device; do not use a household teaspoon (overdosage may occur).
Dietary supplement: As a vitamin D dietary supplement
Osteoporosis, prevention; Vitamin D insufficiency/deficiency
Cholecalciferol may be confused with alfacalcidol, ergocalciferol
Liquid vitamin D preparations have the potential for dosing errors when administered to infants. Droppers should be clearly marked to easily provide 400 units. For products intended for infants, the FDA recommends that accompanying droppers deliver no more than 400 units per dose.
No adverse reactions listed in the manufacturer's labeling.
OTC labeling: Replesta products only: When used for self-medication, do not use if you have hypercalcemia, primary hyperparathyroidism, sarcoidosis, hypervitaminosis D, Williams syndrome, or are pregnant.
Documentation of allergenic cross-reactivity for vitamin D is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Concerns related to adverse effects:
• Vitamin D toxicity: May occur with excessive doses; symptoms may include nausea, vomiting, loss of appetite, constipation, dehydration, fatigue, irritability, confusion, weakness and/or weight loss. Effects of vitamin D can last ≥2 months after therapy is discontinued.
Disease related concerns:
• Hyperphosphatemia: Normal serum phosphorous concentrations must be maintained in patients treated for hyperphosphatemia to prevent metastatic calcification.
Dosage form specific issues:
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP 1997; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer's labeling.
Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP, 1997; Shehab, 2009).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aluminum Hydroxide: Vitamin D Analogs may increase the serum concentration of Aluminum Hydroxide. Specifically, the absorption of aluminum may be increased, leading to increased serum aluminum concentrations. Management: Consider avoiding chronic use of aluminum and aluminum-containing products in patients who are also taking vitamin D analogs. If coadministered, monitor aluminum status and for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification
Bile Acid Sequestrants: May decrease the serum concentration of Vitamin D Analogs. More specifically, bile acid sequestrants may impair absorption of Vitamin D Analogs. Management: Avoid concomitant administration of vitamin D analogs and bile acid sequestrants (eg, cholestyramine). Separate administration of these agents by several hours to minimize the potential risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification
Calcium Salts: May enhance the adverse/toxic effect of Vitamin D Analogs. Risk C: Monitor therapy
Cardiac Glycosides: Vitamin D Analogs may enhance the arrhythmogenic effect of Cardiac Glycosides. Risk C: Monitor therapy
Danazol: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy
Erdafitinib: Serum Phosphate Level-Altering Agents may diminish the therapeutic effect of Erdafitinib. Management: Avoid coadministration of serum phosphate level-altering agents with erdafitinib before initial dose increase period based on serum phosphate levels (Days 14 to 21). Risk D: Consider therapy modification
Mineral Oil: May decrease the serum concentration of Vitamin D Analogs. More specifically, mineral oil may interfere with the absorption of Vitamin D Analogs. Management: Avoid concomitant, oral administration of mineral oil and vitamin D analogs. Consider separating the administration of these agents by several hours to minimize the risk of interaction. Monitor plasma calcium concentrations. Risk D: Consider therapy modification
Multivitamins/Fluoride (with ADE): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Multivitamins/Minerals (with ADEK, Folate, Iron): May enhance the adverse/toxic effect of Vitamin D Analogs. Risk X: Avoid combination
Orlistat: May decrease the absorption of Vitamins (Fat Soluble). Management: Administer oral fat soluble vitamins at least 2 hours before or 2 hours after the administration of orlistat. Avoid concomitant administration due to the risk of impaired vitamin absorption. Risk D: Consider therapy modification
Sucralfate: Vitamin D Analogs may increase the serum concentration of Sucralfate. Specifically, the absorption of aluminum from sucralfate may be increased, leading to an increase in the serum aluminum concentration. Management: Consider avoiding chronic use of aluminum and aluminum-containing products, such as sucralfate, in patients who are also taking vitamin D analogs. If combined, monitor for signs and symptoms of aluminum-related toxicities. Risk D: Consider therapy modification
Thiazide and Thiazide-Like Diuretics: May enhance the hypercalcemic effect of Vitamin D Analogs. Risk C: Monitor therapy
Vitamin D Analogs: May enhance the adverse/toxic effect of other Vitamin D Analogs. Risk X: Avoid combination
The cholecalciferol metabolite, 25(OH)D, crosses the placenta; maternal serum concentrations correlate with fetal concentrations at birth (Misra 2008; Wagner 2008).
Adequate maternal vitamin D is required for fetal growth and development (Misra 2008). Vitamin D deficiency in a pregnant woman may lead to a vitamin D deficiency in the neonate (Misra 2008; Wagner 2008). Serum 25(OH)D concentrations should be measured in pregnant women considered to be at increased risk of deficiency (ACOG 2011). The amount of vitamin D contained in prenatal vitamins may not be adequate to treat a deficiency during pregnancy; although larger doses may be needed, current guidelines recommend a total of 1,000 to 2,000 units/day (25 to 50 mcg/day) until more safety data is available (ACOG 2011). In women not at risk for deficiency, doses larger than the RDA should be avoided during pregnancy (ACOG 2011; IOM 2011).
Cholecalciferol is present in breast milk (Oberhelman 2013).
Following administration of vitamin D as cholecalciferol, concentrations of cholecalciferol and 25(OH)D increase in the maternal serum and may correlate with breast milk concentrations (Oberhelman 2013).
Vitamin D is present in breast milk following normal maternal exposure via sunlight and diet (Wagner 2008). Vitamin D in breast milk is primarily vitamin D3 (cholecalciferol) and 25(OH)D3 (við Streym 2016). The amount of endogenous vitamin D in breast milk is insufficient to provide an exclusively breastfed child the recommended intake of vitamin D (Misra 2008). In addition, premature infants, infants born to vitamin D deficient mothers, dark-skinned children, children living at high latitudes, and exclusively breastfed infants and children may be at increased risk for vitamin D deficiency. Therefore, vitamin D supplementation is recommended in all infants who are partially or exclusively breast fed (IOM 2011; Misra 2008; Wagner 2008).
Maternal vitamin D requirements are the same for breastfeeding and nonbreastfeeding females (IOM 2011). Although administration of cholecalciferol in doses larger than the maternal RDA may increase 25(OH)D in breast milk, the actual maternal dose needed to provide the infant with an adequate amount of vitamin D is still under study (Wagner 2008)
Vitamin D is found in egg yolks, fatty fish, fortified milk, fortified cereal, and infant formulas; it is also produced by exposure to sunlight (IOM 2011).
Dietary Reference Intake for Vitamin D (IOM 2011):
0 to 12 months: Adequate intake: 10 mcg/day (400 units/day)
1 to 70 years: RDA: 15 mcg/day (600 units/day)
>70 years: RDA: 20 mcg/day (800 units/day)
Pregnancy/Lactating: RDA: 15 mcg/day (600 units/day)
Signs and symptoms of vitamin D toxicity (eg hypercalcemia, hypercalcuria, confusion, psychosis, tremor, calcification of soft tissues, nausea, weakness) (ASPEN [McKeever 2017]).
Adults:
Serum 25(OH)D: For patients being treated for vitamin D deficiency with a baseline serum 25(OH)D level <20 ng/mL (50 nmol/L), measure ~3 to 4 months after initiation or dosage adjustment. In healthy patients initiating maintenance dosing, routine monitoring is not required (Dawson-Hughes 2022).
Additional monitoring of calcium, phosphorous, parathyroid hormone (PTH), alkaline phosphatase may be required depending on severity of 25(OH)D deficiency and/or concomitant clinical conditions (eg, chronic kidney disease, hypoparathyroidism) (Dawson-Hughes 2022; ES [Brandi 2016]; KDIGO 2017).
Infants, Children, and Adolescents:
Vitamin D deficiency: Monitor serum calcium, phosphorus and alkaline phosphatase (ALP) one month after starting therapy; serum calcium, phosphorous, magnesium, ALP, 25(OH)D, and PTH as well as x-ray (may also consider urine calcium/creatinine ratio) after 3 months; 25(OH)D yearly (Misra 2008).
Increased risk of vitamin D deficiency (chronic fat malabsorption, chronic antiseizure medication use): Serum 25(OH)D, PTH, and bone mineral status (baseline). If vitamin D supplement is required, repeat 25(OH)D levels at 3-month intervals until normal. PTH and bone mineral status should be monitored every 6 months until normal. (Wagner 2008).
CKD: Measure serum 25(OH)D levels after 3 months of treatment. Measure corrected total calcium and phosphorous after 1 month and then at least every 3 months (KDOQI 2009).
Vitamin D deficiency: There is no clear consensus on a reference range for total serum 25(OH)D concentrations or the validity of this level as it relates clinically to bone health. In addition, there is significant variability in the reporting of serum 25 (OH)D levels as a result of different assay types in use. However, the following ranges have been suggested:
Adults:
<12 ng/mL (30 nmol/L): At risk for deficiency (IOM 2011).
12 to 20 ng/mL (30 to 50 nmol/L): Potentially at risk for inadequacy (IOM 2011).
≥20 ng/mL (50 nmol/L): Sufficient levels in practically all persons (IOM 2011).
>40 ng/mL (100 nmol/L): Increased risk of falls have been reported in elderly females with levels >40 ng/mL (Smith 2017) or ~48 ng/mL (120 nmol/L) (Sanders 2010).
>50 ng/mL (125 nmol/L): There are insufficient data to determine the safe upper limit of serum 25(OH)D. Serum 25(OH)D levels above approximately 50 ng/mL (125 nmol/L) should be avoided (IOM 2011).
Osteoporosis patients: Recommended level to reach and maintain may vary by guideline/organization: ≥20 ng/mL (50 nmol/L) is considered adequate according to some experts (ES [Eastell 2019]); others suggest a goal of ~30 ng/mL (75 nmol/L) (NOF [Cosman 2014]).
Children (Misra 2008):
<15 ng/mL (37.5 nmol/L): At risk for deficiency.
15 to 20 ng/mL (37.5 to 50 nmol/L): Potentially at risk for inadequacy.
≥20 ng/mL (50 nmol/L): Sufficient levels in practically all children.
>100 ng/mL (250 nmol/L): Concern for risk of toxicity.
Cholecalciferol (vitamin D3) is a provitamin. The active metabolite, 1,25-dihydroxyvitamin D (calcitriol), stimulates calcium and phosphate absorption from the small intestine, promotes secretion of calcium from bone to blood; promotes renal tubule phosphate resorption (IOM 2011)
Absorption: Absorbed in the small intestine; fat soluble; requires bile (IOM 2011)
Metabolism: Inactive until hydroxylated hepatically to 25-hydroxyvitamin D [25(OH)D; calcifediol] then renally to the active metabolite 1,25-dihydroxyvitamin D (calcitriol) (IOM 2011)
Half-life, circulating: 25(OH)D: 2 to 3 weeks; 1,25-dihydroxyvitamin D: ~4 hours
Excretion: Feces (IOM 2011)
Capsules (D3-50 Oral)
1.25 MG(50000 UT) (per each): $0.21
Capsules (Decara Oral)
1.25 MG(50000 UT) (per each): $1.19
625 MCG(25000 UT) (per each): $1.91
Capsules (Dialyvite Vitamin D 5000 Oral)
125 MCG(5000 UT (per each): $0.13
Capsules (Pronutrients Vitamin D3 Oral)
25 MCG(1000 UT) (per each): $0.07
Capsules (Weekly-D Oral)
1.25 MG(50000 UT) (per each): $1.10
Liquid (BProtected Pedia D-Vite Oral)
10 mcg/mL (per mL): $0.18
Liquid (D-Vi-Sol Oral)
10 mcg/mL (per mL): $0.20
Tablets (Dialyvite 5000 Oral)
5 mg (per each): $0.56
Tablets (Dialyvite Vitamin D3 Max Oral)
1.25 MG(50000 UT) (per each): $1.08
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
