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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00886379
First Posted: April 22, 2009
Last Update Posted: April 22, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  Purpose
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 Intervention 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
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Enrollment: 744
Study Start Date: January 2009
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

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 Submitted: April 20, 2009
First Posted: April 22, 2009
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