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Drugs and Health Products

Monograph: Vitamin D

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Date: 2007-08-16

NHPID Name

Vitamin D (NHPD 2007a)

Proper Name(s)

Vitamin D ( Sweetman 2007 , IOM 2003 , O'Neil et al. 2001 )

Common Name(s)

Source Material


The slash (/) indicates that the terms are synonyms. Either term may be selected by the applicant

Route Of Administration

Oral

Dosage Form(s)

  • The acceptable pharmaceutical dosage forms include, but are not limited to capsules, chewables (e.g. gummies, tablets), liquids, powders, strips or tablets.
  • This monograph is not intended to include foods or food-like dosage forms such as bars, chewing gums or beverages.

Use(s) or Purpose(s)

Statement(s) to the effect of:

General
A factor in the maintenance of good health  (IOM 2006, IOM 1997)

Specific

Dose-specific
For products providing daily doses of Vitamin D at or above the Adequate Intake (AI):
Helps to prevent vitamin D deficiency  (IOM 2006, Shils et al. 2006, Groff and Gropper 2000, IOM 1997)

Dose(s)

Children and adolescents 0 - 13 years:

Dose(s): 0.2 - 25 Micrograms per day

Adults and adolescents 14 and over:

Dose(s): 0.8 - 25 Micrograms per day

  • Adults includes pregnant and breastfeeding women.
  • Conversion Factors: 1 IU of vitamin D activity = 0.025 microgram cholecalciferol (IOM 2006); and, 1 IU of vitamin D activity = 0.025 microgram ergocalciferol
  • The maximum daily value is based on the Food and Drug Regulations Schedule F limit (HC 2007).
  • The minimum daily doses are based on approximately 5% of the highest AI (IOM 2006). See Appendix 1 for definitions and Table 2 in Appendix 2 for AI values.

Duration of use

No statement is required

Risk Information

Statement(s) to the effect of:

Caution(s) and Warning(s):
No statement is required

Contraindication(s):
No statement is required

Known Adverse Reaction(s):
No statement is required

Non-medicinal ingredients

Must be chosen from the current Natural Health Products Ingredients Database and must meet the limitations outlined in the database.

Specifications

  • The finished product specifications must be established in accordance with the requirements described in the NHPD Quality of Natural Health Products Guide.
  • The medicinal ingredient must comply with the requirements outlined in the Natural Health Products Ingredient Database (NHPID).

References cited

  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • IOM 1997 : Institute of Medicine. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine. Dietary Reference Intakes for Calcium, Phosphorous, Magnesium, Vitamin D, and Fluoride. Washington (DC) : National Academy Press; 1997.
  • IOM 2003: Institute of Medicine. Committee on Food Chemicals Codex, Food and Nutrition Board, Institute of Medicine. Food Chemicals Codex, 5th edition. Washington (DC): National Academies Press; 2003.
  • IOM 2006: Institute of Medicine. Otten JJ, Pitzi Hellwig J, Meyers LD, editors. Institute of Medicine. Dietary Reference Intakes: The Essential Guide to Nutrient Requirements. Washington (DC): National Academies Press; 2006.
  • JC 2008: Justice Canada. Food and Drug Regulations. (C.01.021). Ottawa (ON): Health Canada; 2008. [Accessed 2008-01-31] Available from: http://laws.justice.gc.ca/en/F-27/C.R.C.-c.870/text.html
  • NIH 2000: National Institute of Health. Osteoporosis Prevention, Diagnosis, and Therapy. NIH Consensus Statement Online 2000;17(1):1-36. Bethesda (MD): National Institute of Health; March 27-29, 2000. [Accessed 2007-03-21]. Available from: http://www.consensus.nih.gov/2000/2000Osteoporosis111html.htm
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 13th edition. Whitehouse Station (NJ): Merck & Co., Inc.; 2001.
  • Shils ME, Olson JA, Shike M, Ross AC, Caballero B, Cousins RJ, editors. Modern Nutrition in Health and Disease, 10th edition. Philadelphia (PA): Lippincott Williams & Wilkins; 2006.
  • Sweetman SC , editor. Martindale: The Complete Drug Reference, 35th edition. London (UK): Pharmaceutical Press; 2007.

Appendix 1: Definitions

Adequate Intake (AI): The recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people that are assumed to be adequate; used when a Recommended Dietary Allowance (RDA) cannot be determined (IOM 2006).

Recommended Dietary Allowances (RDA): The average daily dietary nutrient intake level sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group (IOM 2006).

Appendix 2: AI Values

The AI values for vitamin D are provided below. For the purpose of this monograph, these values are intended to:

  • provide targets for setting appropriate supplement dosage levels;
  • provide the minimum dose for the use of the dose-specific use or purpose: "Helps to prevent vitamin D deficiency";
  • facilitate the optional labelling of % AI values.
Table 1: Adequate Intake values for vitamin D based on life stage group (IOM 2006)
Life stage group Vitamin D (g/day)
Infants 0-12 mo 5
Children 1-3 y 5
4-8 y 5
Adolescents 9-13 y 5
14-18 y 5
Adults 19-50 y 5
51-70 y 10
≥ 70 y 15
Pregnancy 14-50 y 5
Breastfeeding 14-50 y 5