Vitamin D3-enhanced Eggs in Preschool Children (NCT06096194) | Clinical Trial Compass
CompletedNot Applicable
Vitamin D3-enhanced Eggs in Preschool Children
Mexico275 participantsStarted 2018-07-15
Plain-language 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.
Who can participate
Age range
12 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Children with an egg allergy
* Chldren with hypersensitivity to vitamin D
* Children who have taken vitamin D supplements in the past month
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Serum 25-OH-D
Timeframe: At baseline and at 12 weeks of intervention
Trial details
NCT IDNCT06096194
SponsorInstituto Nacional de Salud Publica, Mexico