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

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00886379
First received: April 20, 2009
Last updated: April 21, 2009
Last verified: April 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
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

Ages Eligible for Study:   9 Years to 11 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
Additional 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
Study First Received: April 20, 2009
Last Updated: April 21, 2009
Health Authority: United States: Institutional Review Board

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
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 22, 2014