Community Interventional Trial (CITFOMIST)

Tehran University of Medical Sciences

Status: Completed

Conditions: Vitamin D Deficiency

Treatments: Dietary Supplement: 200 IU Milk; Dietary Supplement: Non-Fortified Milk; Dietary Supplement: 120 IU milk

Study type: Interventional

Funder types: Other

Identifiers

NCT02035423

EMRI-1390

CITFOMIST (Other Identifier)

Details and patient eligibility

About

The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011. The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 IU Vit D/1000cc, milk that contained 1000 IU Vit D /1000cc -- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Full description

The cluster randomized trial (CITFOMIST) was conducted on 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital, in winter 2011.

The 36 schools enrolled in this study were randomly assigned to receive one of the three groups of milk -- whole milk, milk that contained 600 international unit (IU) Vit D/1000cc (120IU), milk that contained 1000 IU Vit D /1000cc (200IU)-- for a 30-day period. In order to study the effect of vitamin D-fortified milk on the circulating concentrations of 25(OH)D, a serum vitamin D levels were checked in a subgroup before and after the intervention.

Enrollment: 6,000 patients

Sex: All

Ages: 15 to 19 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 15-19-year old guidance and high school students of both genders from different districts of Tehran, the Iranian capital

Exclusion criteria

• Those taking vitamin D supplements
• Those with underlying disease affecting bone health
• Those taking medication affecting bone metabolism
• Those taking fortified products on a regular basis
• Those following special diets

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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6,000 participants in 4 patient groups

Male Guidance School

Active Comparator group

Description:

Non-Fortified Milk 120IU Milk 200IU Milk

Treatment:

Dietary Supplement: Non-Fortified Milk

Dietary Supplement: 120 IU milk

Dietary Supplement: 200 IU Milk

Female Guidance

Active Comparator group

Description:

Non-fortified Milk 120IU Milk 200IU Milk

Treatment:

Dietary Supplement: Non-Fortified Milk

Dietary Supplement: 120 IU milk

Dietary Supplement: 200 IU Milk

Male Highschool

Active Comparator group

Description:

Non-Fortified Milk 120IU Milk 200IU Milk

Treatment:

Dietary Supplement: Non-Fortified Milk

Dietary Supplement: 120 IU milk

Dietary Supplement: 200 IU Milk

Female Highschool

Active Comparator group

Description:

Non-Fortified Milk 120IU Milk 200IU Milk

Treatment:

Dietary Supplement: Non-Fortified Milk

Dietary Supplement: 120 IU milk

Dietary Supplement: 200 IU Milk