Status:
COMPLETED
Aflatoxin Birth Cohort Study Nepal (AflaCohort)
Lead Sponsor:
Tufts University
Collaborating Sponsors:
Helen Keller International
Patan Academy of Health Sciences
Conditions:
Stunting
Birth Weight
Eligibility:
FEMALE
16-49 years
Brief Summary
The study focuses on the causal relationship between mycotoxin exposure (particularly aflatoxin B1), birth outcomes, and height for age among young children in Nepal. Previous studies have shown a str...
Detailed Description
In 2012, a research prioritization meeting organized by IFPRI and the Bill and Melinda Gates Foundation on food-borne toxins concluded, "While there is solid association of stunting with exposure to m...
Eligibility Criteria
Inclusion
- Pregnant women and adolescent girls (less than 30 weeks gestation)
- Aged 16-49 years
- Living in the study area
- Intends to reside in the study area through the study period
- Intends to deliver in the study area
- Provides informed consent herself or through a legal guardian
- Live Birth
- Single Birth
Exclusion
- Severely malnourished mother \<17.5 cm
- Severely anemic mother hemoglobin\<7 g/dL
- Pregnancy induced hypertension
- Congenital anomalies
- Very low birth weight \<1500 g
- Sepsis
- Respiratory distress syndrome
- Severe malnutrition infant ≤-3 WFH z-score (3 months), \<11.5 cm MUAC or edema
- Severe anemia infant (hemoglobin\<7 g/dL)
- Fetal loss
- Early termination of pregnancy
- Still births
- Infant death
- Relocation of household
Key Trial Info
Start Date :
July 6 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
1675 Patients enrolled
Trial Details
Trial ID
NCT03312049
Start Date
July 6 2015
End Date
March 31 2019
Last Update
May 10 2019
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