Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
NCT ID: NCT00886379
Last Updated: 2021-03-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
597 participants
INTERVENTIONAL
2009-01-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Mongolian milk without D
Mongolian milk without vitamin D
710ml per day for 49 days
2
Mongolian milk with vitamin D
Mongolian milk with vitamin D
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
3
Ultra High Temperature (UHT) milk
UHT milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
4
Milk Substitute
Milk Substitute
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
5
Seasonal D
Seasonal D supplement
Deliver dosage of 13,700 IU vitamin D over 7 days
6
Daily D
Daily D supplement
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Interventions
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Mongolian milk without vitamin D
710ml per day for 49 days
Mongolian milk with vitamin D
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
UHT milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Milk Substitute
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Seasonal D supplement
Deliver dosage of 13,700 IU vitamin D over 7 days
Daily D supplement
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
9 Years
11 Years
ALL
Yes
Sponsors
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Brigham and Women's Hospital
OTHER
Responsible Party
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Janet Rich-Edwards
Direct of Developmental Epidemiology
Principal Investigators
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Janet Rich-Edwards, Sc.D.
Role: PRINCIPAL_INVESTIGATOR
Brigham and Women's Hospital
References
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Rich-Edwards JW, Ganmaa D, Pollak MN, Nakamoto EK, Kleinman K, Tserendolgor U, Willett WC, Frazier AL. Milk consumption and the prepubertal somatotropic axis. Nutr J. 2007 Sep 27;6:28. doi: 10.1186/1475-2891-6-28.
Rich-Edwards JW, Ganmaa D, Kleinman K, Sumberzul N, Holick MF, Lkhagvasuren T, Dulguun B, Burke A, Frazier AL. Randomized trial of fortified milk and supplements to raise 25-hydroxyvitamin D concentrations in schoolchildren in Mongolia. Am J Clin Nutr. 2011 Aug;94(2):578-84. doi: 10.3945/ajcn.110.008771. Epub 2011 Jun 22.
Other Identifiers
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BSS-103306
Identifier Type: -
Identifier Source: org_study_id
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