CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 585 enrolled
Drug / intervention
fortified milk +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00864539
NCT00864539Phase 3Completed

The Prevalence of Vitamin D Insufficiency in Primary School Children and Comparison of the Effect of Calcium-Vitamin D-Fortified Milk, -Orange Juice and Calcium-Vitamin D Supplement

National Nutrition and Food Technology Institute·interventional·Posted Mar 18, 2009·Updated Nov 21, 2011

In Brief

A Phase 3 clinical trial evaluating fortified milk, plain milk, and 4 other interventions for Vitamin D Status and Healthy. Completed, enrolled 585 participants.

Detailed Summary

This study is conducted in two phases. At the first phase, the prevalence of vitamin D insufficiency in primary school-children in Tehran is determined during the cold seasons of 2008. Then, the efficacy of calcium-vitamin D-fortified milk, -orange juice and supplement is compared in six selected primary schools.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 18, 2009
Enrollment StartNov 1, 2007
Primary CompletionFeb 1, 2009
Study CompletionJun 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.3 years ago

Interventions

fortified milkdietary

daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200 ml package for 10 weeks

plain milkdietary

daily intake of 200 ml plain milk

fortified orange juicedietary

daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium/250 ml package

plain orange juicedietary

daily intake of 250 ml plain orange juice

calcium-vitamin D supplementdietary

daily calcium-vitamin D supplement (500 mg calcium + 200 IU vitamin D)

Placebodietary

daily placebo