Trial of Vitamin D Fortified Milk

A Randomized Trial of Milk Fortified With Vitamin D in Colombia

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01909622

Enrollment

Registered

2013-07-26

Start date

2013-06-30

Completion date

2016-10-31

Last updated

2016-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

25-hydroxyvitamin D Serum Concentrations

Keywords

Vitamin D, Milk fortification, Children, Colombia

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.

Interventions

DIETARY_SUPPLEMENTVitamin D

DIETARY_SUPPLEMENTNo vitamin D

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

144 Months to 174 Months

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Serum concentrations of 25-OH vitamin D	up to 6 weeks

Countries

Colombia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026