Effects of Complementary Feeding of Eggs on Infant Development and Growth in Guatemala: The Saqmo… (NCT04316221) | Clinical Trial Compass
CompletedNot Applicable
Effects of Complementary Feeding of Eggs on Infant Development and Growth in Guatemala: The Saqmolo Study
Guatemala1,200 participantsStarted 2021-04-01
Plain-language summary
The specific aims of this study are:
In a randomized controlled trial, the investigators will evaluate the impact of daily egg consumption during the complementary feeding period in addition to the local standard of nutrition care (i.e., intervention group), compared to the local standard of nutrition care alone (i.e., control group) on the following outcomes, in infants that are \~6-month old at baseline:
1. Child development, as measured by global development scores (primary outcome)
2. Growth, as measured by anthropometrics (secondary outcome)
3. Diet quality, as measured by the World Health Organization infant and young child feeding indicators (secondary outcome)
Hypothesis: The investigators hypothesize that daily consumption of eggs during the complementary feeding period, in addition to the local standard of nutrition care, will improve child development, growth, and diet quality compared to the local standard of care alone.
Who can participate
Age range
6 Months – 9 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:
* Infants who are 6.0-9.0 months of age at baseline
* At least one caregiver willing to provide oral informed consent
* Planned residence in the study area for approximately the next 18 months
* Singleton birth
Exclusion Criteria:
* Infants with moderate to severe acute malnutrition (weight-for-length z-score \< -2)
* Infants with severe anemia (Hgb \<7 g/dL per WHO guidelines, with adjustments for altitude as necessary)
* Infants with a chronic medical condition that affects growth (e.g., congenital heart disease, genetic condition) as determined by the MHA staff physician
* Infants whose caregivers have cognitive or other impairments that prevent them from being able to provide informed consent or to reliably provide information required for the developmental assessments
* Infants with a known egg allergy
* Infants with recalcitrant, moderate-to-severe atopic dermatitis
* Infants with a history of anaphylaxis or serious allergic reaction to any substance requiring emergency medical care
* Concurrent participation in any other clinical trial
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
Caregiver Reported Child Development Instruments (CREDI)