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

NCT03544671 | Completed DMC

• 1 other identifier: 114-7000
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Vitamin D; Nutritional deficiencies; Miconutrients; Children; Mexico

Outcome Measures

Primary Outcomes (3)

• Chanche in 400UI,of vitamin D2 over 25-Hidroxi Vitamin D

  nmol/L

  Measurements were taken at baseline, and at 16 weeks

• Chanche in 800UI,of vitamin D2 over 25-Hidroxi Vitamin D

  nmol/L

  Measurements were taken at baseline, and at 16 weeks

• Change in 1000 of vitamin D3 over 25-Hidroxi Vitamin D

  nmol/L

  Measurements were taken at baseline, and at 16 weeks

Study Arms (4)

400 IU/d vitamin D2

EXPERIMENTAL

Children received 1mililiter (dosage applicator) containing 400 IU of vitamin D2 per day. This suplement also contained: iron, vitamin A, C, and E, folic acid, niacin and vitamins B1, B2, B6 y B12. Vitamin D2, dosage form (1 mililiter), frequency (daily) and duration 16 weeks

Dietary Supplement: Vitamin D

800 IU7d vitmin D2

EXPERIMENTAL

Children received 2 mililiter (dosage applicator) containing 800 IU of vitamin D2 per day. This suplement also contained: iron, vitamin A, C, and E, folic acid, niacin and vitamins B1, B2, B6 y B12. Vitamin D2, dosage form (1 mililiter), frequency (daily) and duration 16 weeks

Dietary Supplement: Vitamin D

1000 IU vitamina D3

EXPERIMENTAL

Children received 1drop (dosage applicator) containing 1000 IU of vitamin D3 per day. dosage form (1 drop), frequency (daily) and duration 16 weeks

Dietary Supplement: Vitamin D

Multiple vitamin

PLACEBO COMPARATOR

Children received 1 mililiter of a supplement with multiple vitamins (dosage applicator) frequency (daily) and duration 16 weeks

Dietary Supplement: Vitamin D

Interventions

Vitamin D DIETARY_SUPPLEMENT

1000 IU vitamina D3; 400 IU/d vitamin D2; 800 IU7d vitmin D2; Multiple vitamin

Eligibility Criteria

• Age: 12 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children form 12-30 months of who attend the day care centers Children whose parents accepted their child to participate and sign the informed consent

You may not qualify if:

• Children receiving multiple micronutrient supplementation/ other vitamin D suplement
• Children whose parents did not accept to participate
• Children with capillary hemoglobin concentration \<9.0 g/dL at baseline

Sponsors & Collaborators

• Instituto Nacional de Salud Publica, Mexico: lead
• DSM Nutritional Products, Inc.: collaborator

Study Sites (1)

Marta Rivera Pasquel

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

Vitamin D Deficiency; Vitamin D Hydroxylation-Deficient Rickets, Type 1B; Malnutrition

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Secosteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Mario Flores, PhD

  National Institute of Public Health, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The Moses Oakford method was used by an independent researcher to randomly assign each child to 1 of 3 groups to receive the administration of the three supplments. A computer was used to generate the random numbers (STATA v.13). Groups were stratified by age from 12- 18 months, from 19- 24 months and form 25- 30 months of age. Each block group was assigned 73 children.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mario Flores-Aldana, MD, PhD Nutrition Surveillance, Director

Model Details: Double blind, randomized, parallel, controlled trial was conducted in children from 12 to 30 months of age who received four supplements. Four treatments groups were assign randomly to children: One group received 400 IU/d, the second group received 800IU/d of vitamin D2 and the third one 1,000IU/d of colecalciferol D3. The fourth group-control-group- received a multy vitamin supplementation containing: iron, vitamin A, C, and E, folic acid, niacin and vitamins B1, B2, B6 y B12.Children were enrolled from 14-day-care centers which are part of a national government program Secretaria de Desarrollo Social "SEDESOL" , which main objective is to support working mothers and those who intend to work and do not have access to a health service.

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: June 4, 2018
• Study Start: September 15, 2016
• Primary Completion: June 18, 2017
• Study Completion: December 21, 2017
• Last Updated: June 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)