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Can Correction of Low Vitamin D Status in Infancy Program for a Leaner Body Composition?

NCT02563015 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 139

Last updated 2025-06-11

No results posted yet for this study

Summary

One in four infants are born with low amounts of vitamin D stored in their body. This study is designed to test whether improving vitamin D status quickly after birth helps infants to build muscle and to normalize growth. This is important since the investigators have noticed in previous work that infants with low vitamin D have higher body weight relative to body length later on and that those who develop very good stores quickly have a leaner body type. Therefore, in this study infants with low stores early after birth will be given either the regular amount of supplementation or a higher amount to more rapidly build up the vitamin stores in the body. Infants in both groups will be measured for muscle and fat mass at standardized ages during the first year of life and into the toddler years. The information will inform health care professionals and parents of the importance of establishing good vitamin D stores early in life. Vitamin D supplementation is a modifiable factor that is already recommended for all term born infants. Knowing how much is needed in infants born with low stores has not been tested in a controlled manner in Canada.

Conditions

  • Healthy
  • Vitamin D Deficiency
  • Gestational Diabetes

Interventions

DIETARY_SUPPLEMENT

cholecalciferol

liquid drops

DIETARY_SUPPLEMENT

Reference 400

liquid drops

Sponsors & Collaborators

Principal Investigators

  • Hope Weiler, PhD. · McGill University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Week
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-03-07
Primary Completion
2020-09-20
Completion
2020-09-20

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 NCT02563015 on ClinicalTrials.gov