Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 597
- Primary Endpoint
- Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Study Overview
Brief Summary
This intervention study will address the impact of vitamin D fortified milk and vitamin D supplements on the growth, levels of vitamin D, insulin-like growth factor 1, growth hormone, academic attention, respiratory infections, asthma, and flexural dermatitis (a proxy for eczema) of Mongolian children.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Care Provider)
Eligibility Criteria
- Ages
- 9 Years to 11 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children in 3rd and 4th grade from selected Mongolian schools.
- •School selection will consider:
- •socioeconomic position;
- •geographic location;
- •school size;
- •current lunch or supplementation program; and
- •the interest and willingness to participate of the school's administration and faculty.
Exclusion Criteria
- •Allergy to milk or wheat products.
Arms & Interventions
1
Mongolian milk without D
Intervention: Mongolian milk without vitamin D (Dietary Supplement)
2
Mongolian milk with vitamin D
Intervention: Mongolian milk with vitamin D (Dietary Supplement)
3
Ultra High Temperature (UHT) milk
Intervention: UHT milk (Dietary Supplement)
5
Seasonal D
Intervention: Seasonal D supplement (Dietary Supplement)
4
Milk Substitute
Intervention: Milk Substitute (Dietary Supplement)
6
Daily D
Intervention: Daily D supplement (Dietary Supplement)
Outcomes
Primary Outcomes
Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
Time Frame: Blood was analyzed at day 0 and day 49
Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
Secondary Outcomes
No secondary outcomes reported
Investigators
Janet Rich-Edwards
Direct of Developmental Epidemiology
Brigham and Women's Hospital