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

NCT ID: NCT00886379

Last Updated: 2021-03-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

597 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2009-03-31

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.

Detailed Description

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Conditions

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Vitamin d Deficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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1

Mongolian milk without D

Group Type ACTIVE_COMPARATOR

Mongolian milk without vitamin D

Intervention Type DIETARY_SUPPLEMENT

710ml per day for 49 days

2

Mongolian milk with vitamin D

Group Type EXPERIMENTAL

Mongolian milk with vitamin D

Intervention Type DIETARY_SUPPLEMENT

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

Group Type EXPERIMENTAL

UHT milk

Intervention Type DIETARY_SUPPLEMENT

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

4

Milk Substitute

Group Type EXPERIMENTAL

Milk Substitute

Intervention Type DIETARY_SUPPLEMENT

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

5

Seasonal D

Group Type EXPERIMENTAL

Seasonal D supplement

Intervention Type DIETARY_SUPPLEMENT

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

6

Daily D

Group Type EXPERIMENTAL

Daily D supplement

Intervention Type DIETARY_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

Intervention Type DIETARY_SUPPLEMENT

Mongolian milk with vitamin D

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

Intervention Type DIETARY_SUPPLEMENT

UHT milk

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

Intervention Type DIETARY_SUPPLEMENT

Milk Substitute

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

Intervention Type DIETARY_SUPPLEMENT

Seasonal D supplement

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

Intervention Type DIETARY_SUPPLEMENT

Daily D supplement

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

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Guum milk Guum milk Gossner milk Mead Johnson Tish Con Tish Con

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Janet Rich-Edwards

Direct of Developmental Epidemiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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.

Reference Type BACKGROUND
PMID: 17900364 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21697075 (View on PubMed)

Other Identifiers

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BSS-103306

Identifier Type: -

Identifier Source: org_study_id

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