Trial of Vitamin D Fortified Milk

Study Overview
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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.

Official Title
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A Randomized Trial of Milk Fortified With Vitamin D in Colombia

Conditions
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25-hydroxyvitamin D Serum Concentrations

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: No vitamin D


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 144 Months
Maximum Age: 174 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D-fortified milk<br>Skim milk fortified with 600 IU vitamin D3 / 250 mL | Dietary Supplement: Vitamin D<br> <br> |
| Active Comparator: Vitamin D-unfortified milk<br>Unfortified skim milk | Dietary Supplement: No vitamin D<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentrations of 25-OH vitamin D |  | up to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vitamin D, Milk fortification, Children, Colombia