Study Comparing Two Isoforms of Vitamin D Supplements for Infants

This study has been completed.
Sponsor:
Collaborator:
Canadian Foundation for Dietetic Research (CFDR)
Information provided by (Responsible Party):
Hope Weiler, McGill University
ClinicalTrials.gov Identifier:
NCT01190137
First received: August 26, 2010
Last updated: March 1, 2012
Last verified: March 2012
  Purpose

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
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 McGill University:

Primary Outcome Measures:
  • Equivalency of isoforms [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   up to 6 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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 ClinicalTrials.gov identifier: NCT01190137

Locations
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)
Investigators
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

Additional Information:
No publications provided by McGill University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hope Weiler, Associate Professor, McGill University
ClinicalTrials.gov Identifier: NCT01190137     History of Changes
Other Study ID Numbers: A09-M108-09A
Study First Received: August 26, 2010
Last Updated: March 1, 2012
Health Authority: Canada: Ethics Review Committee

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

Additional relevant MeSH terms:
Cholecalciferol
Ergocalciferols
Vitamin D
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 19, 2014