Study Comparing Two Isoforms of Vitamin D Supplements for Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01190137
Recruitment Status : Completed
First Posted : August 27, 2010
Last Update Posted : March 2, 2012
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Hope Weiler, McGill University

Brief Summary:
There are two different types of vitamin D - vitamin D3 (animal source) and vitamin D2 (plant source). Almost all the usual vitamin D preparations for infants available in Canadian pharmacies contain vitamin D3 which may not be suitable for families who avoid animal products for social or religious reasons. The purpose of this study is to learn more about the two forms of vitamin D and if blood levels of vitamin D are similar in infants after taking them. Forty-eight breastfed infants will be randomly assigned to 400 IU of either vitamin D2 or D3 supplement for 3 months starting at 1 month of age. The difference in blood vitamin D levels, after 3 months of supplementation, between the two groups will help determine if the two supplements are equal.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2) Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Bio-equivalency Study of the Effects of Vitamin D2 and Vitamin D3 Supplements on 25-hydroxyvitamin D Levels in Exclusively Breast Fed Canadian Infants
Study Start Date : March 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 400 IU Vitamin D3 Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2)
400 IU administered as 1 drop daily for 3 months
Other Name: Baby D Drops

Experimental: 400 IU Vitamin D2 Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2)
400 IU administered as 1 drop daily for 3 months
Other Name: Baby D Drops

Primary Outcome Measures :
  1. Equivalency of isoforms [ Time Frame: 3 months ]
    To compare the relative ability of daily oral supplementation of 400 IU in the form of vitamin D3 or D2 to achieve and sustain optimal plasma 25(OH)D concentrations, defined as 25(OH)D values between 75-225 nmol/L, in exclusively breastfed infants.

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Healthy, singleton term infants of appropriate for gestational age, according to Centers for Disease Control (CDC) growth charts based on weight at birth between 5th and 95th percentiles for sex
  • Born to healthy breastfeeding women
  • Exclusively breast fed infants from birth, according to WHO definition: breast milk, expressed breast milk, vitamins, minerals and medicine but not including water, breast milk substitutes, other liquids and solid foods.

Exclusion Criteria:

  • Infants of mothers with a history of gestational diabetes or hypertension in pregnancy; chronic alcohol use; malabsorption syndromes (Celiac disease, Crohn's, etc.), due to malabsorption of fat soluble vitamins
  • Mothers taking any medications that can affect vitamin D metabolism (anticonvulsants and corticosteroids)
  • Mothers taking ≥ 2,000 IU/d of vitamin D from supplementation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01190137

Canada, Quebec
Mary Emily Clinical Nutrition Research Unit
Ste. Anne de Bellevue, Quebec, Canada, H9X 3V9
Sponsors and Collaborators
McGill University
Canadian Foundation for Dietetic Research (CFDR)
Principal Investigator: Hope A, Weiler, PhD, RD McGill University
Principal Investigator: Celia Rodd, MD Montreal Children's Hospital, McGill University Health Center
Principal Investigator: Sina Gallo, MSc, RD McGill University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hope Weiler, Associate Professor, McGill University Identifier: NCT01190137     History of Changes
Other Study ID Numbers: A09-M108-09A
First Posted: August 27, 2010    Key Record Dates
Last Update Posted: March 2, 2012
Last Verified: March 2012

Keywords provided by Hope Weiler, McGill University:
Optimal vitamin D status
25-hydroxy vitamin D
Rickets and bone mineralization
Breast fed infants
Cholecalciferol and ergocalciferol

Additional relevant MeSH terms:
Vitamin D
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents