NCT00886379

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
597

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2009

Shorter than P25 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2009

Completed
11.9 years until next milestone

Results Posted

Study results publicly available

March 23, 2021

Completed
Last Updated

March 23, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

April 20, 2009

Results QC Date

May 28, 2019

Last Update Submit

February 26, 2021

Conditions

Vitamin d Deficiency

Keywords

vitamin dchildrenMongolia

Outcome Measures

Primary Outcomes (1)

  • Serum 25-hydroxyvitamin D Concentrations in Schoolchildren

    Baseline and Follow-up 25(OH)D3 by liquid chromatography-tandem mass spectrometry

    Blood was analyzed at day 0 and day 49

Study Arms (6)

1

ACTIVE COMPARATOR

Mongolian milk without D

Dietary Supplement: Mongolian milk without vitamin D

2

EXPERIMENTAL

Mongolian milk with vitamin D

Dietary Supplement: Mongolian milk with vitamin D

3

EXPERIMENTAL

Ultra High Temperature (UHT) milk

Dietary Supplement: UHT milk

4

EXPERIMENTAL

Milk Substitute

Dietary Supplement: Milk Substitute

5

EXPERIMENTAL

Seasonal D

Dietary Supplement: Seasonal D supplement

6

EXPERIMENTAL

Daily D

Dietary Supplement: Daily D supplement

Interventions

Mongolian milk without vitamin DDIETARY_SUPPLEMENT

710ml per day for 49 days

Also known as: Guum milk
1
Mongolian milk with vitamin DDIETARY_SUPPLEMENT

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

Also known as: Guum milk
2
UHT milkDIETARY_SUPPLEMENT

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

Also known as: Gossner milk
3
Milk SubstituteDIETARY_SUPPLEMENT

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

Also known as: Mead Johnson
4
Seasonal D supplementDIETARY_SUPPLEMENT

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

Also known as: Tish Con
5
Daily D supplementDIETARY_SUPPLEMENT

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

Also known as: Tish Con
6

Eligibility Criteria

Age9 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Allergy to milk or wheat products.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 17900364BACKGROUND

  • 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.

    PMID: 21697075DERIVED

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Vitamin DMilk Substitutes

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Results Point of Contact

Title
Dr. Janet Rich-Edwards
Organization
Brigham and Women's Hospital
jr33@partners.org
617-525-7929

Study Officials

  • Janet Rich-Edwards, Sc.D.

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Direct of Developmental Epidemiology

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 22, 2009

Study Start

January 1, 2009

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 23, 2021

Results First Posted

March 23, 2021

Record last verified: 2021-02