Vitamin D3-enhanced Eggs in Preschool Children

NCT06096194 | Completed DMC

• 1 other identifier: FM/DI/0282018
• Study Type: interventional
• Target: 275
• Locations: 1 country
• Sites: 1

Brief 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:

• 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

Keywords

Vitamin D3; enhanced egg; Vitamin D3-enhanced egg; 25-Hydroxyvitamin D3 Deficiency; supplementation; Mexico; Children

Outcome Measures

Primary Outcomes (1)

• Serum 25-OH-D

  nmol/L

  At baseline and at 12 weeks of intervention

Secondary Outcomes (1)

• Serum PTH

  At baseline and at 12 weeks of intervention

Other Outcomes (7)

• Insulin

  At baseline and at 12 weeks of intervention

• Weight

  At baseline and at 12 weeks of intervention

• Height

  At baseline and at 12 weeks of intervention

Study Arms (2)

vitamin D3-enhanced egg

EXPERIMENTAL

The experimental group consumed an vitamin D3-enhanced egg (\~ 400 IU). The randomization unit was the take care SEDESOL centers. All children in 3 day-care centers were given one vitamin D3-enhanced egg at breakfast, 3 times a week for 12 weeks (Monday, Wednesday and Friday).

Dietary Supplement: vitamin D-enhanced egg

Control

PLACEBO COMPARATOR

The control group consumed unfortified egg (\~ 43 IU Vitamin D). The randomization unit was the 6 day-care centers (SEDESOL). All children in 3 day-care centers were given unfortified egg at breakfast, 3 times a week for 12 weeks (Monday, Wednesday and Friday).

Other: Control

Interventions

vitamin D-enhanced egg DIETARY_SUPPLEMENT

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

vitamin D3-enhanced egg

Control OTHER

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

Control

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children of either sex, from 12 to 59 months of age who attend take care SEDESOL centers
• Children who consume eggs within their usual diet at least 5 times per month
• Childrens whose parents or legal guardian agree to participate in the study and sign an informed consent letter

You may not qualify if:

• Children with an egg allergy
• Chldren with hypersensitivity to vitamin D
• Children who have taken vitamin D supplements in the past month

Sponsors & Collaborators

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

Study Sites (1)

Instituto Nacional de Salud Pública

Cuernavaca, Morelos, 62100, Mexico

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

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

Study Officials

• Mario E Flores Aldana, PhD

  National Institute of Public Health, Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Two types of eggs. Control egg and fortified egg (vitamin D3-enhanced egg), only the researcher in charge of eggs production was not blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mario Flores-Aldana, MD, PhD Nutrition Surveillance, Director

Model Details: Randomized Double Blind field trial

Study Record Dates

• First Submitted: September 4, 2023
• First Posted: October 23, 2023
• Study Start: July 15, 2018
• Primary Completion: November 30, 2018
• Study Completion: December 21, 2019
• Last Updated: October 23, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)