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

Primary Purpose

Vitamin d Deficiency

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Mongolian milk without vitamin D
Mongolian milk with vitamin D
UHT milk
Milk Substitute
Seasonal D supplement
Daily D supplement
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Vitamin d Deficiency focused on measuring vitamin d, children, Mongolia

Eligibility Criteria

9 Years - 11 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    1

    2

    3

    4

    5

    6

    Arm Description

    Mongolian milk without D

    Mongolian milk with vitamin D

    Ultra High Temperature (UHT) milk

    Milk Substitute

    Seasonal D

    Daily D

    Outcomes

    Primary Outcome Measures

    Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
    Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry

    Secondary Outcome Measures

    Full Information

    First Posted
    April 20, 2009
    Last Updated
    February 26, 2021
    Sponsor
    Brigham and Women's Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00886379
    Brief Title
    Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
    Acronym
    BSS
    Official Title
    Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2009 (undefined)
    Primary Completion Date
    March 2009 (Actual)
    Study Completion Date
    March 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vitamin d Deficiency
    Keywords
    vitamin d, children, Mongolia

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    597 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    Mongolian milk without D
    Arm Title
    2
    Arm Type
    Experimental
    Arm Description
    Mongolian milk with vitamin D
    Arm Title
    3
    Arm Type
    Experimental
    Arm Description
    Ultra High Temperature (UHT) milk
    Arm Title
    4
    Arm Type
    Experimental
    Arm Description
    Milk Substitute
    Arm Title
    5
    Arm Type
    Experimental
    Arm Description
    Seasonal D
    Arm Title
    6
    Arm Type
    Experimental
    Arm Description
    Daily D
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mongolian milk without vitamin D
    Other Intervention Name(s)
    Guum milk
    Intervention Description
    710ml per day for 49 days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Mongolian milk with vitamin D
    Other Intervention Name(s)
    Guum milk
    Intervention Description
    710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    UHT milk
    Other Intervention Name(s)
    Gossner milk
    Intervention Description
    710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Milk Substitute
    Other Intervention Name(s)
    Mead Johnson
    Intervention Description
    710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Seasonal D supplement
    Other Intervention Name(s)
    Tish Con
    Intervention Description
    Deliver dosage of 13,700 IU vitamin D over 7 days
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Daily D supplement
    Other Intervention Name(s)
    Tish Con
    Intervention Description
    Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
    Primary Outcome Measure Information:
    Title
    Serum 25-hydroxyvitamin D Concentrations in Schoolchildren
    Description
    Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry
    Time Frame
    Blood was analyzed at day 0 and day 49

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    9 Years
    Maximum Age & Unit of Time
    11 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Janet Rich-Edwards, Sc.D.
    Organizational Affiliation
    Brigham and Women's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    17900364
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    21697075
    Citation
    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.
    Results Reference
    derived

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

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