Early Child Development and Nutrition in Guatemala (NCT02302729) | Clinical Trial Compass
CompletedNot Applicable
Early Child Development and Nutrition in Guatemala
Guatemala1,730 participantsStarted 2015-02-16
Plain-language summary
Over 200 million children under the age of 5 years in low and middle-income countries do not reach their developmental potential, largely due to lack of adequate nutrients and lack of psychosocial stimulation. Stunting (length-for-age \< -2 z-scores) is an indication of chronic undernutrition. Guatemala has the high rates of stunting in the Western Hemisphere (over 40%). This trial examines the effect of providing a micronutrient powder manufactured in Guatemala vs. placebo and an early learning environment vs. no early learning environment on the growth, health, and development of young children in Guatemala.
Who can participate
Age range
6 Months – 4 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:
* Child speaks Spanish.
* Child is age 6-12 months or age 36-48 months.
* Child must be undernourished (length and height for age \< -1 z-score).
* Child does not have any obvious health or developmental problems that would interfere with growth, nutrition, or development.
* Child will remain in the area for the subsequent year.
* Parent or legal guardian of the child is age 18 years or older.
* Parent or legal guardian speaks and understands Spanish.
* Parent or legal guardian lives with child in study community.
Exclusion Criteria:
* Child is not age 6-12 months or 36-48 months.
* Child has severe stunting (length and height for age \< -3 z-scores).
* Child has identified conditions that could interfere with their development and growth.
* Child is severely anemic (hemoglobin \< 7).
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
Change in cognitive, motor, social-emotional development from baseline to 12 months