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

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ClinicalTrials.gov Identifier: NCT00886379
Recruitment Status : Completed
First Posted : April 22, 2009
Last Update Posted : April 22, 2009
Sponsor:
Information provided by:
Brigham and Women's Hospital

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.

Condition or disease Intervention/treatment Phase
Vitamin D Deficiency Dietary Supplement: Mongolian milk without vitamin D Dietary Supplement: Mongolian milk with vitamin D Dietary Supplement: UHT milk Dietary Supplement: Milk Substitute Dietary Supplement: Seasonal D supplement Dietary Supplement: Daily D supplement Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 744 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Blue Sky Study: Impact of Milk and Vitamin D for Child Growth and Health
Study Start Date : January 2009
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Active Comparator: 1
Mongolian milk without D
Dietary Supplement: Mongolian milk without vitamin D
710ml per day for 49 days
Other Name: Guum milk

Experimental: 2
Mongolian milk with vitamin D
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.
Other Name: Guum milk

Experimental: 3
UHT milk
Dietary Supplement: UHT milk
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Other Name: Gossner milk

Experimental: 4
Milk Substitute
Dietary Supplement: Milk Substitute
710ml per day for 49 days. A total of 13,700 IU of vitamin D over the intervention period.
Other Name: Mead Johnson

Experimental: 5
Seasonal D
Dietary Supplement: Seasonal D supplement
Deliver dosage of 13,700 IU vitamin D over 7 days
Other Name: Tish Con

Experimental: 6
Daily D
Dietary Supplement: Daily D supplement
Deliver dosage of 13,700 IU vitamin D in vitamin capsules over 49 days.
Other Name: Tish Con





Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00886379


Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Janet Rich-Edwards, Sc.D. Brigham and Women's Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Janet Rich-Edwards, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00886379     History of Changes
Other Study ID Numbers: BSS-103306
First Posted: April 22, 2009    Key Record Dates
Last Update Posted: April 22, 2009
Last Verified: April 2009

Keywords provided by Brigham and Women's Hospital:
vitamin d
children
Mongolia

Additional relevant MeSH terms:
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents