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Study Comparing Two Isoforms of Vitamin D Supplements for Infants

NCT01190137 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2012-03-02

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Cholecalciferol (D3) or ergocalciferol (D2)

400 IU administered as 1 drop daily for 3 months

Sponsors & Collaborators

  • Canadian Foundation for Dietetic Research (CFDR)

    collaborator OTHER

  • McGill University

    lead OTHER

Principal Investigators

  • Hope A, Weiler, PhD, RD · McGill University

  • Celia Rodd, MD · Montreal Children's Hospital, McGill University Health Center

  • Sina Gallo, MSc, RD · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Weeks
Max Age
6 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Canada

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01190137 on ClinicalTrials.gov