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25-Hydroxyvitamin D3 Deficiency, Selective clinical trials

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NCT ID: NCT03544671 Completed - Clinical trials for Vitamin D Deficiency

Effect of Vitamin D3 Supplementation in Children From 12 to 30 Months of Age.

Start date: September 15, 2016
Phase: N/A
Study type: Interventional

Background Vitamin D (VD) is essential for calcium absorption, bone health and growth in children. In a national representative sample authors found mean serum concentration of 25-Hydroxi-Vitamin-D (25-OH-D) of 59 nmol/L, in children < 5 y of age. Prevalence deficiency of VD under 50 nmol/L was 33%, which means that 3 million preschool- age children have VD deficiency in Mexico. Additionally, less than 3% of the children use supplements with VD. Objective To assess the effect of 400UI, 800IU of vitamin D2 and 1000IU of vitamin D3-colecalciferol- over 25-Hidroxi Vitamin D (25-OH-D) status and a multiple vitamin supplementation per day as a control group in children from 12-30 months of age in Cuernavaca, Morelos in a 4 month period. Methods Randomized double blind parallel clinical trial, with vitamin D3 (colecalciferol) supplementation in 220 children from 12 - 30 months who attend day care centers. Three supplementations will be given to children: 400IU and 800IU of vitamin D2, the third group 1000IU of D3-colecalciferol- and the control group will receive a multi vitamin supplementation. The duration of the intervention will be 16 weeks. Blood measurements would be taken at baseline, and at 16 weeks. This study compares the efficacy of three dose of VD in children from 12-30 months of age, over the nutritional status of 25 hydroxivitamin D (25-OH-D). This intervention is of importance to establish supplementation strategies to prevent VD deficiency in Mexico. Keywords: Vitamin D, nutritional deficiencies, micronutrients, children, México.