NCT Number: NCT01909622
Trial of Vitamin D Fortified Milk
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.
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Notify MeKey information
Conditions
Age range
144 month–174 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 3
Primary location
FINUSAD - Foundation for Research in Nutrition and Health, Bogotá, Colombia
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
No vitamin D
Dietary SupplementPrimary outcomes
-
Serum concentrations of 25-OH vitamin D
Time frame: up to 6 weeks
Sponsors and collaborators
Lead sponsor
University of Michigan
Other
Registry information
Official study title
A Randomized Trial of Milk Fortified With Vitamin D in Colombia
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2016
- First posted
- Jul 26, 2013
- Registry last updated
- Oct 27, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.