Abstract
BACKGROUND: As prevention of osteoporosis becomes more imperative with the global ageing of the population, establishing different measures to fight vitamin D deficiency will also become increasingly important. The aim of this study is to help assess the efficacy of vitamin D–fortified milk on circulating concentrations of 25(OH)D (as the primary outcome), a widely accepted indicator of vitamin D status, in Tehran students. Another objective of the protocol is to help assess the compliance with fortified dairy in students of different socioeconomic classes.
METHOD: The cluster-randomized trial (CITFOMIST) is conducted on 15- to19-year olds guidance and high school students of both genders from different districts of Tehran, in wintertime. The schools enrolled in this study are randomly assigned to receive one of the three groups of milk (whole milk, milk that contained 600 IU Vit D/1000cc, or 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 are checked in a subgroup before and after the intervention.
CONCLUSION: There are few data on the efficacy of incremental doses of vitamin D from fortified foods among adolescents. This is while developing an optimal model to fight vitamin D deficiency needs further research on bone health outcomes and the safety of vitamin D-fortified products. The modified version of this protocol could be applied in different parts of the country to assess the efficacy of a vitamin-D product.