This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Study Comparing Two Isoforms of Vitamin D Supplements for Infants

This study has been completed.
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Hope Weiler, McGill University Identifier:
First received: August 26, 2010
Last updated: March 1, 2012
Last verified: March 2012
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 Intervention Phase
Healthy Dietary Supplement: Cholecalciferol (D3) or ergocalciferol (D2) Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Hope Weiler, McGill University:

Primary Outcome Measures:
  • 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.

Enrollment: 52
Study Start Date: March 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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
Study First Received: August 26, 2010
Last Updated: March 1, 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 processed this record on September 18, 2017