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Vitamin D3-enhanced Eggs in Preschool Children

NCT06096194 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 275

Last updated 2023-10-23

No results posted yet for this study

Summary

This is double-blind, controlled fiel trial, to compare fortified egg with D3-or 25(OH)D3 and non-fortified eggs in healthy preschool-age children 12 to 60 months of age, affiliated to day-care centers at Secretaria de Desarrollo Social (SEDESOL).

The study aims to answer are:

1. to evaluate the efficacy of fortified egg with vitamian D3 on serum concentrations of 25-hydroxyvitamin D3
2. and to evaluate parathyroid hormone (PTH) in children aged 12 to 60 months of age.

* Children would be given for breakfast fortified egg/non-foritfied egg three times per week for 12 weeks.
* Blood samples will be taken at baseline and at the end of study.
* Anthropometric meassurements weight /height will be taken at baseline and at end of study.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

vitamin D-enhanced egg

In our study, the vitamin D3-enhanced eggs were produced by hens that received 23,500 IU of vitamin D3 per kg of feed. Which does not confer them any harm or danger of intoxication. This experiment was carried out at the Center for Teaching, Research and Extension in Poultry Production (CEIEPAv, FMVZ-UNAM) and lasted 40 weeks. This ensured that the hens eggs were enhanced with vitamin D achieving a final concentration of approximately 400 IU of vitamin D

OTHER

Control

Unfortified eggs were used for the control group with a concentration of approximately 43 IU of vitamin D

Sponsors & Collaborators

  • DSM Nutritional Products, Inc.

    collaborator INDUSTRY

  • Instituto Nacional de Salud Publica, Mexico

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-15
Primary Completion
2018-11-30
Completion
2019-12-21

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 NCT06096194 on ClinicalTrials.gov