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

Mass General Brigham

Status and phase: Completed; Phase 2

Conditions: Vitamin d Deficiency

Treatments: Dietary Supplement: Mongolian milk without vitamin D; Dietary Supplement: Seasonal D supplement; Dietary Supplement: Mongolian milk with vitamin D; Dietary Supplement: UHT milk; Dietary Supplement: Milk Substitute; Dietary Supplement: Daily D supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT00886379

BSS-103306

Details and patient eligibility

About

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.

Enrollment: 597 patients

Sex: All

Ages: 9 to 11 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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597 participants in 6 patient groups

1

Active Comparator group

Description:

Mongolian milk without D

Treatment:

Dietary Supplement: Mongolian milk without vitamin D

2

Experimental group

Description:

Mongolian milk with vitamin D

Treatment:

Dietary Supplement: Mongolian milk with vitamin D

3

Experimental group

Description:

Ultra High Temperature (UHT) milk

Treatment:

Dietary Supplement: UHT milk

4

Experimental group

Description:

Milk Substitute

Treatment:

Dietary Supplement: Milk Substitute

5

Experimental group

Description:

Seasonal D

Treatment:

Dietary Supplement: Seasonal D supplement

6

Experimental group

Description:

Daily D

Treatment:

Dietary Supplement: Daily D supplement