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Community Interventional Trial (CITFOMIST)

Community Interventional Trial (CITFOMIST) to Study the Efficacy and Compliance of Different Degrees of Vitamin D Fortified Milk

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02035423
Acronym
CITFOMIST
Enrollment
6000
Registered
2014-01-14
Start date
2011-01-31
Completion date
2011-06-30
Last updated
2014-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vitamin D Deficiency

Keywords

Vitamin D Deficiency, Compliance, Milk

Brief summary

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.

Detailed 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.

Interventions

DIETARY_SUPPLEMENT120 IU milk

Daily consumption of milk fortified with 120 IU vitamin D

DIETARY_SUPPLEMENT200 IU Milk

Daily Consumption of milk fortified with 200 IU vitamin D

DIETARY_SUPPLEMENTNon-Fortified Milk

Daily consumption of non-fortified milk

Sponsors

UNICEF
CollaboratorOTHER
Tehran University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Compliance with milk consumption1 month

Secondary

MeasureTime frame
Serum 25(OH)D levels1 month

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026