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Study Comparing Two Vitamin D Supplements for Infants: Liquid Versus D-Strips

NCT00846677 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2012-03-02

No results posted yet for this study

Summary

Vitamin D supplementation (400 IU/d) is recommended for all breastfed infants in Canada. Such recommendation is grounded in the fact that the prevalence of rickets in Canada is higher than desirable, likely due to low maternal-fetal transfer and low intakes postpartum.

There is little data about adherence to supplementation in Canada, but one study shows that in primiparous mothers (n=1937) in Quebec, 58.1 % of those exclusively breast-feeding gave their infant vitamin D supplements in the first six months and 62.1 % of those feeding formula did not. For the Canadian situation, it is not clear if the modality of the supplementation is a barrier to providing the supplement. Thus the overall aim of this study is to test a new delivery system for parental preference and infant acceptance compared to a standard vitamin D supplement.

Conditions

  • Healthy

Interventions

DIETARY_SUPPLEMENT

Vitamin D, cholecalciferol

Oral Quick Dissolve Strip, 400 IU once per day for 21 days

DIETARY_SUPPLEMENT

Vitamin D, cholecalciferol

Oral Syrup, 400IU per day for 21 days

Sponsors & Collaborators

Principal Investigators

  • Hope A Weiler, PhD · McGill University

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • Canada

Study Locations

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Entities

Companies

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 NCT00846677 on ClinicalTrials.gov