Trial of Vitamin D Fortified Milk

NCT01909622 | Completed Phase 3

• 1 other identifier: VDFORT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Vitamin D; Milk fortification; Children; Colombia

Outcome Measures

Primary Outcomes (1)

• Serum concentrations of 25-OH vitamin D

  up to 6 weeks

Study Arms (2)

Vitamin D-fortified milk

EXPERIMENTAL

Skim milk fortified with 600 IU vitamin D3 / 250 mL

Dietary Supplement: Vitamin D

Vitamin D-unfortified milk

ACTIVE COMPARATOR

Unfortified skim milk

Dietary Supplement: No vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

Vitamin D-fortified milk

No vitamin D DIETARY_SUPPLEMENT

Vitamin D-unfortified milk

Eligibility Criteria

• Age: 144 Months - 174 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age between 144 and 174 completed months by the time of enrollment.
• Intention to stay in the city for the next six weeks.
• Children living with their biological mothers.
• Families own a refrigerator.

You may not qualify if:

• History of illness involving calcium or bone metabolism, including stones of the urinary tract.
• Currently taking vitamin D supplements as treatment of any disease.
• Receiving immunosuppressive therapy (oral corticosteroids, chemotherapy) during the previous year.
• Known history of lactose intolerance or other contra-indications or aversion to milk intake.
• Known hypercalcemia.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

FINUSAD - Foundation for Research in Nutrition and Health

Bogotá, Colombia

Location

University of La Sabana

Chía, Colombia

Location

MeSH Terms

Interventions

Vitamin D

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mercedes Mora, MSc, RD

  FINUSAD - Foundation for Research in Nutrition and Health

  STUDY DIRECTOR

• Henry Oliveros, MD, MSc

  University of La Sabana

  STUDY DIRECTOR

• Eduardo Villamor, MD, DrPH

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 24, 2013
• First Posted: July 26, 2013
• Study Start: June 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2016
• Last Updated: October 27, 2016

Record last verified: 2016-10

Locations

CO (2)