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Drugs and Health Products

Monograph: Calcium

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This monograph is intended to serve as a guide to industry for the preparation of Product Licence Applications (PLA) and labels for natural health product market authorization. It is not intended to be a comprehensive review of the medicinal ingredient. It is a referenced document to be used as a labelling standard. Note: Text in parentheses is additional optional information which can be included on the PLA and product labels at the applicants' discretion. The solidus (/) indicates that the terms are synonyms or that the statements are synonymous. Either term or statement may be selected by the applicant.

Date: 2009-06-23

NHPID Name

Calcium (O'Neil et al. 2012)

Proper Name(s)

Calcium ( Sweetman 2007 , O'Neil et al. 2006 )

Common Name(s)

Calcium ( Sweetman 2007 , O'Neil et al. 2006 )

Source Material


When bone meal is used as a source material for calcium, it must be sourced from a non-human animal that is not susceptible to Transmissible Spongiform Encephalopathy (TSE) diseases, including Bovine Spongiform Encephalopathy (BSE) (HC 2006). When an HAP or an HVP chelate is used as a source material, this product is for an adult population only.

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 Calcium at or above the Adequate Intake (AI) :
Helps to prevent calcium deficiency  (IOM 2006, Shils et al. 2006, Groff and Gropper 2000, IOM 1997)

Dose(s)

Adults, adolescents and children 1 year and older:

Dose(s): 65 - 1500 Milligrams per day
Directions For Use: Take a few hours before or after taking other medications (Sweetman 2007, ASHP 2005)


  • Adults includes pregnant and breastfeeding women.
  • The maximum daily dose is based on the Tolerable Upper Intake Level (UL) less average dietary intake (adapted from IOM 2006).
  • 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).
  • The medicinal ingredient may comply with the specifications outlined in the applicable calcium monographs published in the USA (USP), British (BP) and European (Ph. Eur.) Pharmacopoeias.

References cited

  • Albion 1993: Calcium absorption conflict. Albion Research Notes 1993;2(2) [Accessed 2007-03-21]. Available from: http://www.albion-an.com/human/Newsletter/1993Mar.pdf
  • Albion 1996: Effective calcium supplementation: not as easy as advertised!!! Albion Research Notes 1996;5(3) [Accessed 2007-03-21]. Available from: http://www.albion-an.com/human/Newsletter/1996june.pdf
  • Albion 2000: Implications of the "other half" of a mineral compound. Albion Research Notes 2000;9(3) [Accessed 2007-05-18]. Available from: http://www.albion-an.com/human/Newsletter/2000October.pdf
  • ASHP 2005: American Society of Health-System Pharmacists. American Hospital Formulary Service (AHFS) Drug Information. Philadelphia (PA): Lippincott Williams and Wilkins; 2005.
  • BP 2008: British Pharmacopoeia, Volume 1. Londron (UK): British Pharmacopoeia Commission. The Stationary Office.
  • Brown JP, Josse RG. 2002. Clinical Practice Guidelines for the Diagnosis and Management of Osteoporosis in Canada. Canadian Medical Association Journal 167(S10):S1-S34
  • European Pharmacopoeia, 6th edition. Strasbourg (France): Directorate for the Quality of Medicines and HealthCare of the Council of Europe (EDQM).; 2008
  • FDA 2008: United States Food and Drug Administration. Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis. [online] Federal Register, Volume 73, Number 189, September 29, 2008, Final Rules. Docket Number FDA-2004-P-0205 (formerly Docket Number 2004P-0464) Rockville (MD): Department of Health and Human Services, U.S. Food and Drug Administration. [Accessed 2009 June 23].Available from: http://www.fda.gov/OHRMS/DOCKETS/98fr/E8-22730.pdf
  • Groff J, Gropper S. Advanced Nutrition and Human Metabolism, 3rd edition. Belmont (CA): Wadsworth/Thomson Learning; 2000.
  • HC 2006: Health Canada. Evidence for Safety and Efficacy of Finished Natural Health Products. Ottawa (ON): Natural Health Products Directorate, Health Canada; 2006. [Accessed 2012-01-30] Available from: http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/efe-paie_eng.php
  • HC 2008: Health Canada. 2008. Drug Product Database [online]. Ottawa (ON): Health Canada. [Accessed 2009 April 17]. Available from: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/databasdon/index-eng.php
  • 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.
  • NAMS (The North American Menopause Society). 2006. Position Statement - The role of calcium in peri- and postmenopausal women: 2006 position statement of The North American Menopause Society. The Journal of the North American Menopause Society 13(6):862-877
  • 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.
  • O'Neil MJ, Smith A, Heckelman PE, Budavari S, editors. 2006. The Merck Index: An Encyclopedia of Chemicals, Drugs, and Biologicals, 14th edition. Whitehouse Station (NJ): Merck & Co., Inc.
  • Patrick L. Comparative absorption of calcium sources and calcium citrate malate for the prevention of osteoporosis. Alternative Medicine Review 1999;4(2):74-85.
  • 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.
  • Tang BMP, Eslick GD, Nowson C, Smith C, Bensoussan A. 2007. Use of calcium or calcium in combination with vitamin D supplementation to prevent fracture and bone loss in people aged 50 years and older: a meta-analysis. Lancet 370(9588):657-666
  • USP 32 : United States Pharmacopeial Convention. 2009. United States Pharmacopeia and the National Formulary (USP 32 - NF 27). Rockville (MD): The United States Pharmacopeial Convention.

References reviewed

  • Chapuy MC, Arlot ME, Duboeuf F, Brun J, Crouzet B, Arnaud S, Delmas PD, Meunier PJ. 1992. Vitamin D3 and calcium to prevent hip fractures in elderly women. The New England Journal of Medicine 327(23):1637-1642
  • Health Canada. 2007. Canadian Community Health Survey Cycle 2.2, Nutrition (2004). A Guide to Accessing and Interpreting the Data. [online]. Office of Nutrition Policy and Promotion. Health Products and Food Branch. [Accessed 2009 May 21] Available from: http://www.hc-sc.gc.ca/fn-an/alt_formats/hpfb-dgpsa/pdf/surveill/cchs-guide-escc_e.pdf
  • Prestwood KM, Pannullo AM, Kenny AM, Pilbearn CC, Raisz LG. 1996; The effect of a short course of calcium and vitamin D on bone turnover in older women. Osteoporosis International 6(4):314-319
  • Ruml LA, Sakhaee K, Peterson R, Adams-Huet B, Pak CY. 1999. The effect of calcium citrate on bone density in the early and mid-postemenopausal period : a randomized placebo-controlled study. American Journal of Therapeutics 6(6):303-311

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. An AI is used when an 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).

Tolerable Upper Intake Level (UL):

The highest average daily nutrient intake level that is likely to pose no risk of adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects may increase (IOM 2006).

Appendix 2: AI Values

The AI values for calcium 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 calcium deficiency";
  • facilitate the optional labelling of % AI values.
Table 1: Adequate Intake (AI) values for calcium based on life stage group (IOM 2006)
Life stage group Calcium (mg/day)
Children 1-3 y 500
4-8 y 800
Adolescents 9-18 y 1,300
Adults 19-50 y 1,000
≥ 51 y 1,200
Pregnancy 14-18 y 1,300
19-50 y 1,000
Breastfeeding 14-18 y 1,300
19-50 y 1,000