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Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health

Phase 2
Completed
Conditions
Vitamin d Deficiency
Interventions
Dietary Supplement: Milk Substitute
Dietary Supplement: Seasonal D supplement
Dietary Supplement: Mongolian milk without vitamin D
Dietary Supplement: Mongolian milk with vitamin D
Dietary Supplement: Daily D supplement
Dietary Supplement: UHT milk
Registration Number
NCT00886379
Lead Sponsor
Brigham and Women's Hospital
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
597
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
4Milk SubstituteMilk Substitute
5Seasonal D supplementSeasonal D
1Mongolian milk without vitamin DMongolian milk without D
2Mongolian milk with vitamin DMongolian milk with vitamin D
6Daily D supplementDaily D
3UHT milkUltra High Temperature (UHT) milk
Primary Outcome Measures
NameTimeMethod
Serum 25-hydroxyvitamin D Concentrations in SchoolchildrenBlood was analyzed at day 0 and day 49

Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry

Secondary Outcome Measures
NameTimeMethod
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