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Vitamin D Dose-Response Study to Establish Dietary Requirements in Infants

NCT00381914 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2012-03-02

No results posted yet for this study

Summary

The research team is comprised of an expert nutrition scientist and a pediatrician with expertise in endocrinology. Both have world-class experience in assessing bone mass in infancy. Together they have designed a study to determine how much dietary vitamin D is needed to optimize health in infants. This is important since many infants are born with vitamin D deficiency. At present the dosage of vitamin D that is optimal for infant health is unclear and recent research suggests that vitamin D status very early in life has long lasting effects on bone mass and other health issues. Therefore, in a group of healthy infants, this research team will test which dosage of vitamin D is needed to achieve optimal vitamin D status. Optimal vitamin D status will be based on growth, biomarkers of vitamin D and bone status in blood and also general health. The infants will all be breastfed and begin the study at about 2 weeks of age. At 3 months intervals over the first year of life, each infant will be measured for growth, duration of breastfeeding and supplement use plus have a bone density scan to determine changes in bone growth. The data will be helpful to guide health care professionals in providing the best care possible for their infants. It will also be important to the health of populations since dietary recommendations for vitamin D are used to guide fortification of foods and development of evidence based policy around nutrient recommendations and their implementation.

Conditions

  • Vitamin D Deficiency

Interventions

DRUG

Vitamin D

400 IU vitamin D / day

DRUG

Vitamin D

800 IU vitamin D / day

DRUG

Vitamin D

1200 IU vitamin D / day

Sponsors & Collaborators

Principal Investigators

  • Hope A Weiler, PhD · McGill University

  • Celia Rodd, MD · Montreal Children's Hospital of the MUHC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-09-30
Completion
2011-12-31

Countries

  • Canada

Study Locations

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Drugs
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 NCT00381914 on ClinicalTrials.gov