Aflatoxin Birth Cohort Study Nepal (AflaCohort)

NCT03312049 | Completed DMC

• 1 other identifier: USAID AID-OAA-G-14-0000
• Study Type: observational
• Target: 1,675
• Locations: 0 countries
• Sites: N/A

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 strong association of stunting with mycotoxin exposure yet causality has not been proven. Thus, this study will provide a better understanding of the association between maternal and/or early life mycotoxin exposure (rates in the blood and breast milk) and infant and young child growth. This information is essential if we are to more fully understand and effectively address the high rates of stunting in Asia.

Conditions

Stunting; Birth Weight; Birth Length; Height for Age; Linear Growth Failure

Keywords

Aflatoxin B1; Aflatoxin M1; Aflatoxin; Mycotoxin; Stunting; Linear growth; Pregnancy; Birth outcomes; Nepal

Outcome Measures

Primary Outcomes (1)

• Change in Height for Age Z-scores (HAZ)

  Height for Age Z-scores based on the World Health Organization's 2006 Child Growth Standards, HAZ \< -6 and \> 6

  Measured at birth and when infant turns 3, 6, 9, 12, 18 and 24 months of age

Secondary Outcomes (6)

• Aflatoxin M1 (breast milk)

  Measured when infant is 3 months of age

• Low birth weight

  Measured at birth

• Aflatoxin B1 (serum)

  Measured during pregnancy

• Change in infant aflatoxin B1

  Measured when infant turns 3, 6, 12 and 18 months of age

• Fumonisin B, Deoxynivalenol (DON) (urine)

  Measured when infant turns 18 months of age

Eligibility Criteria

• Age: 16 Years - 49 Years
• Gender Eligibility Details: Pregnant women and adolescent girls
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All pregnant women and adolescent girls aged 16-49 years and living in the study areas will be invited to join the study. Women who are less than 30 weeks into their gestation will be eligible to participate if their expected delivery date falls within the enrollment period.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts University: lead
• Helen Keller International: collaborator
• Patan Academy of Health Sciences: collaborator
• Purdue University: collaborator
• Government of Nepal: collaborator
• Nepalgunj Medical College: collaborator

Related Publications (3)

• Lamichhane A, Webb P, Andrews-Trevino J, Pokharel A, Acharya S, Shrestha R, Davis D, Baral K, Wang JS, Xue K, Paudel K, Ghosh S. Dietary determinants of aflatoxin B1-lysine adduct among infants in Nepal. Eur J Clin Nutr. 2022 Nov;76(11):1557-1565. doi: 10.1038/s41430-022-01142-1. Epub 2022 Apr 20.

  PMID: 35444268 DERIVED

• Andrews-Trevino JY, Webb P, Shively G, Kablan A, Baral K, Davis D, Paudel K, Shrestha R, Pokharel A, Acharya S, Wang JS, Xue KS, Ghosh S. Aflatoxin exposure and child nutrition: measuring anthropometric and long-bone growth over time in Nepal. Am J Clin Nutr. 2021 Apr 6;113(4):874-883. doi: 10.1093/ajcn/nqaa397.

  PMID: 33677532 DERIVED

• Andrews-Trevino JY, Webb P, Shively G, Rogers BL, Baral K, Davis D, Paudel K, Pokharel A, Shrestha R, Wang JS, Ghosh S. Relatively Low Maternal Aflatoxin Exposure Is Associated with Small-for-Gestational-Age but Not with Other Birth Outcomes in a Prospective Birth Cohort Study of Nepalese Infants. J Nutr. 2019 Oct 1;149(10):1818-1825. doi: 10.1093/jn/nxz122.

  PMID: 31198947 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum aflatoxin B1-lysine adduct levels Breast milk aflatoxin M1 levels

MeSH Terms

Conditions

Growth Disorders; Birth Weight; Failure to Thrive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Weight; Signs and Symptoms

Study Officials

• Patrick Webb, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Kedar P Baral, MD

  Patan Academy of Health Sciences

  PRINCIPAL INVESTIGATOR

• Shibani Ghosh, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Alexander McFarlane Professor of Nutrition

Study Record Dates

• First Submitted: September 11, 2017
• First Posted: October 17, 2017
• Study Start: July 6, 2015
• Primary Completion: March 31, 2019
• Study Completion: March 31, 2019
• Last Updated: May 10, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share