The INICIO-Guatemala Study
Recruiting
N/A
Interventional Study
Development, Child
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
At a Glance
- Age
- 0 Days – 50
- Sex
- Any
- Study type
- Interventional
- Purpose
- Prevention
- Participants needed
- 400 (estimated)
- Sponsor
- University of North Carolina, Chapel Hill · Other
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About This Trial
The goal of this randomized controlled trial (RCT) is to evaluate an intestinal health-targeted nutritional intervention and a caregiver training program, individually and combined, on childhood neurodevelopment (ND) in rural southwest Guatemala.
The main questions it aims to answer are: what is the impact of an intestinal-targeted nutritional intervention on child ND and what is the added benefi…
Trial Locations
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Eligibility Criteria
The investigators will offer enrollment to pregnant in the Trifinio region of southwest Guatemala and will enroll their newborns after birth.
Inclusion Criteria:
* Pregnant woman in the second trimester of pregnancy
* Pregnant woman =\>15 years of age
* Plan to live in the study area during pregna…
Contacts