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Community Interventional Trial (CITFOMIST)

T

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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