CompletedNot Applicable

Multi-Omic Profiling of a Zinc-Biofortified Maize Intervention in Guatemalan Mothers and Children

Guatemala60 participantsStarted 2022-03-01

Plain-language summary

A trial evaluating the systemic and ecological impact of zinc-biofortified maize consumption on cellular zinc status, inflammatory biomarkers, and gut microbiota composition in a cohort of Guatemalan mothers and children.

Who can participate

Age range

24 Months – 49 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.

Household Inclusion Criteria: * Reside in the target area (Chiquimula Department, Guatemala); * Participating in the World Vision (WV) nutrition program; * Families accustomed to consuming maize; * Interest to participate in an informative session; * Presence of at least one woman of reproductive age (18-49 years) and one index child (12-59 months); * Access to a mobile phone; (7) No concurrent participation in other nutrition or food aid programs. Household exclusion Criteria: * Women with problems understanding the study informed consent and the study survey; * Women with any acute or chronic disease that affected dietary intake or nutritional status; * Children with acute malnutrition 4.Children with any acute or chronic disease that affected dietary consumption or nutritional status; * Households that failed to adhere to the study protocol during the previous intervention period (e.g., sold the study maize or diverted it for animal feed).

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

Cellular Zinc Status (LA:DGLA Ratio)

Timeframe: Up to 10 months (Sept 2022 (baseline) thru August 2023 (final assessment))

Trial details

NCT IDNCT07585318

SponsorInstitute of Nutrition of Central America and Panama

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-31

View on ClinicalTrials.gov More Zinc Deficiency trials

Who can participate

Age range

24 Months – 49 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.