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Completed

NCT Number: NCT00886379

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mongolian milk without vitamin D

Dietary Supplement

710ml per day for 49 days

Other names: Guum milk

Mongolian milk with vitamin D

Dietary Supplement

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

Other names: Guum milk

UHT milk

Dietary Supplement

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

Other names: Gossner milk

Milk Substitute

Dietary Supplement

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

Other names: Mead Johnson

Seasonal D supplement

Dietary Supplement

Deliver dosage of 13,700 IU vitamin D over 7 days

Other names: Tish Con

Daily D supplement

Dietary Supplement

Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.

Other names: Tish Con

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: BSS

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
Apr 22, 2009
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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