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

NCT03544671 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-06-04

No results posted yet for this study

Summary

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.

Conditions

  • Vitamin D Deficiency
  • 25-Hydroxyvitamin D3 Deficiency, Selective

Interventions

DIETARY_SUPPLEMENT

Vitamin D

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    collaborator INDUSTRY

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

  • Mario Flores, PhD · National Institute of Public Health, Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-09-15
Primary Completion
2017-06-18
Completion
2017-12-21

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544671 on ClinicalTrials.gov