Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Tox… (NCT03345147) | Clinical Trial Compass
CompletedNot Applicable
Estimation of Vitamin A Stores in Children and Women in Guatemala and Relation With Potential Toxicity Markers
Guatemala178 participantsStarted 2017-01-13
Plain-language summary
The goal of this study is to assess whether 3-5 years-old children who have Vitamin A intakes above the tolerable upper intake level (UL=900 ug per day) have higher total body Vitamin A stores and biomarkers of excessive vitamin A status, compared to children with Normal Vitamin A intakes (250-600 ug per day).
Who can participate
Age range
3 Years – 5 Years
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 3-5 years old and their mothers
* Child VA intake must be above 250 micrograms/day
* Children must be apparently healthy, Hemoglobin\>9 g/dL at recruitment point, C-reactive protein\<5 mg/L. For Women, Hemoglobin\>10 g/dL, C-reactive protein\<5 mg/L
Exclusion Criteria:
°Children with Congenital or chronical diseases, reported illnesses 1 week before the test. For Women: Pregnancy or lactation, Previously known Chronic Diseases
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
Total Vitamin A stores among 3-5 years-old children, in micromoles
Timeframe: 28-day study period
2
Total dietary vitamin A intake among 3-5 years-old children, in micrograms (ug)
Timeframe: 28-day study period
Trial details
NCT IDNCT03345147
SponsorInstitute of Nutrition of Central America and Panama