Status:
RECRUITING
Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories
Lead Sponsor:
University of Zimbabwe
Collaborating Sponsors:
University of Bern
Insel Gruppe AG, University Hospital Bern
Conditions:
Malnutrition Pregnancy
Malnutrition in Children
Eligibility:
FEMALE
18+ years
Brief Summary
Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to als...
Detailed Description
Background Malnutrition, poor hygiene, lack of access to clean water, infectious diseases, and low access to medicine limit life expectancy and developmental potential of infants in Sub-Saharan Africa...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Cases:
- MUAC ≤23 cm in pregnancy
- ≥18 years' old
- At least 20 weeks' gestational age
- Height ≥150 cm
- Planning to be staying in the study area for the next 3 years
- Willing to participate and comply with all study requirements and procedures.
- Any pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study
- Inclusion criteria for Controls
- Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm
- Haemoglobin level of ≥11g/dL
- ≥18 years' old
- At least 20 weeks' gestational age
- Height ≥150 cm
- Planning to stay in the study area for the next 3 years
- Exclusion Criteria
- Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)
- Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.
Exclusion
Key Trial Info
Start Date :
January 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2032
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT07195006
Start Date
January 27 2025
End Date
December 31 2032
Last Update
September 26 2025
Active Locations (1)
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1
University of Zimbabwe
Harare, Zimbabwe