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

Study Overview
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Brief Summary
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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.

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

Conditions
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Vitamin d Deficiency

Intervention / Treatment
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* Dietary Supplement: Mongolian milk without vitamin D
* Dietary Supplement: Mongolian milk with vitamin D
* Dietary Supplement: UHT milk
* Dietary Supplement: Milk Substitute
* Dietary Supplement: Seasonal D supplement
* Dietary Supplement: Daily D supplement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Mongolian milk without D | Dietary Supplement: Mongolian milk without vitamin D<br>* 710ml per day for 49 days<br>* Other names: Guum milk;|
| Experimental: 2<br>Mongolian milk with vitamin D | Dietary Supplement: Mongolian milk with vitamin D<br>* 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.<br>* Other names: Guum milk;|
| Experimental: 3<br>Ultra High Temperature (UHT) milk | Dietary Supplement: UHT milk<br>* 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.<br>* Other names: Gossner milk;|
| Experimental: 4<br>Milk Substitute | Dietary Supplement: Milk Substitute<br>* 710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.<br>* Other names: Mead Johnson;|
| Experimental: 5<br>Seasonal D | Dietary Supplement: Seasonal D supplement<br>* Deliver dosage of 13,700 IU vitamin D over 7 days<br>* Other names: Tish Con;|
| Experimental: 6<br>Daily D | Dietary Supplement: Daily D supplement<br>* Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.<br>* Other names: Tish Con;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum 25-hydroxyvitamin D Concentrations in Schoolchildren | Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry | Blood was analyzed at day 0 and day 49 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin d, children, Mongolia