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Trial of Vitamin D Fortified Milk

NCT ID: NCT01909622

Last Updated: 2016-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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25-hydroxyvitamin D Serum Concentrations

Keywords

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Vitamin D Milk fortification Children Colombia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Vitamin D-fortified milk

Skim milk fortified with 600 IU vitamin D3 / 250 mL

Group Type EXPERIMENTAL

Vitamin D

Intervention Type DIETARY_SUPPLEMENT

Vitamin D-unfortified milk

Unfortified skim milk

Group Type ACTIVE_COMPARATOR

No vitamin D

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Vitamin D

Intervention Type DIETARY_SUPPLEMENT

No vitamin D

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

144 Months

Maximum Eligible Age

174 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Villamor

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mercedes Mora, MSc, RD

Role: STUDY_DIRECTOR

FINUSAD - Foundation for Research in Nutrition and Health

Henry Oliveros, MD, MSc

Role: STUDY_DIRECTOR

University of La Sabana

Eduardo Villamor, MD, DrPH

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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FINUSAD - Foundation for Research in Nutrition and Health

Bogotá, , Colombia

Site Status

University of La Sabana

Chía, , Colombia

Site Status

Countries

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Colombia

Other Identifiers

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VDFORT

Identifier Type: -

Identifier Source: org_study_id