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

Brigham and Women's Hospital597 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

597

Conditions

Vitamin d Deficiency

Interventions

Mongolian milk without vitamin DDIETARY_SUPPLEMENT

710ml per day for 49 days

Mongolian milk with vitamin DDIETARY_SUPPLEMENT

710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

UHT milkDIETARY_SUPPLEMENT

710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 11 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Serum 25-hydroxyvitamin D Concentrations in Schoolchildren

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

Time frame: Blood was analyzed at day 0 and day 49

Data from ClinicalTrials.gov

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