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Trial of Vitamin D Fortified Milk

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ClinicalTrials.gov Identifier: NCT01909622
Recruitment Status : Completed
First Posted : July 26, 2013
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Eduardo Villamor, University of Michigan

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.

Condition or disease Intervention/treatment Phase
25-hydroxyvitamin D Serum Concentrations Dietary Supplement: Vitamin D Dietary Supplement: No vitamin D Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized Trial of Milk Fortified With Vitamin D in Colombia
Study Start Date : June 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: Vitamin D-fortified milk
Skim milk fortified with 600 IU vitamin D3 / 250 mL
Dietary Supplement: Vitamin D
Active Comparator: Vitamin D-unfortified milk
Unfortified skim milk
Dietary Supplement: No vitamin D



Primary Outcome Measures :
  1. Serum concentrations of 25-OH vitamin D [ Time Frame: up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   144 Months to 174 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01909622


Locations
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Colombia
FINUSAD - Foundation for Research in Nutrition and Health
Bogota, Colombia
University of La Sabana
Chia, Colombia
Sponsors and Collaborators
University of Michigan
Investigators
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Study Director: Mercedes Mora, MSc, RD FINUSAD - Foundation for Research in Nutrition and Health
Study Director: Henry Oliveros, MD, MSc University of La Sabana
Principal Investigator: Eduardo Villamor, MD, DrPH University of Michigan
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Responsible Party: Eduardo Villamor, Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT01909622    
Other Study ID Numbers: VDFORT
First Posted: July 26, 2013    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Keywords provided by Eduardo Villamor, University of Michigan:
Vitamin D
Milk fortification
Children
Colombia
Additional relevant MeSH terms:
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Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents