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Trial of Vitamin D Fortified Milk

NCT01909622 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-10-27

No results posted yet for this study

Summary

Prevalence of VDD is high worldwide, even in sunbathed equatorial regions where it had not been suspected before. The most cost-effective method for reducing population-wide VDD is through fortification of commonly consumed foods. Nevertheless, the efficacy of fortification varies by dose, duration, and population characteristics; and it is currently unknown whether it could be an efficacious public health intervention to curb the VDD epidemic among children living in tropical areas. We propose to conduct a randomized, controlled, double blind trial to assess the effect of vitamin D3 fortification of milk on serum 25-hydroxyvitamin D concentrations in school-age children and their mothers in Bogotá, Colombia. Eighty families with a child participating in an ongoing cohort study will be randomized to receive one liter per day of either skim milk fortified with 600 IU vitamin D3 per 250mL or unfortified skim milk for a six-week period. Caregivers will be instructed to give the index child two cups of milk per day and to distribute the remaining milk to the rest of the family. We will measure serum 25(OH)D concentrations of the children and mothers at baseline and at the end of the intervention period.

Conditions

  • 25-hydroxyvitamin D Serum Concentrations

Interventions

DIETARY_SUPPLEMENT

Vitamin D

DIETARY_SUPPLEMENT

No vitamin D

Sponsors & Collaborators

Principal Investigators

  • Mercedes Mora, MSc, RD · FINUSAD - Foundation for Research in Nutrition and Health

  • Henry Oliveros, MD, MSc · University of La Sabana

  • Eduardo Villamor, MD, DrPH · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
144 Months
Max Age
174 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2013-10-31
Completion
2016-10-31

Countries

  • Colombia

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 NCT01909622 on ClinicalTrials.gov