Maternal EED and Aflatoxin Birth Outcomes Study Uganda

NCT ID: NCT03429257

Last Updated: 2018-02-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 258 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2017-12-01

Brief Summary

This prospective cohort study focuses on the relationship between maternal environmental enteric dysfunction (EED) and maternal aflatoxin B1 exposure and birth outcomes, particularly infant anthropometry and gestational age, in Mukono, Uganda.

Detailed Description

The problem of stunting, which has long-term health and economic consequences both at the individual and population level, persists in low and middle income countries (LMICs). It has been recognized that an estimated 20% of stunting begins in-utero. Although poor maternal nutrition during pregnancy is often blamed, it has been hypothesized that maternal EED status and maternal aflatoxin exposure during pregnancy may also play a role. However, to date, there have been no studies which have attempted to show the association between EED in pregnant women and negative birth outcomes. Furthermore, few studies have examined the association between maternal aflatoxin exposure during pregnancy and negative birth outcomes.

In this prospective cohort study, pregnant women were enrolled at their first prenatal visit and birth outcome data was assessed within 48 hours of delivery. EED was measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS). Aflatoxin exposure was assessed by measuring the serum concentration of AFB1-lysine adduct from a blood sample taken at enrollment. Data on covariates were obtained from two surveys, one at enrollment and one three weeks prior to participant's estimated date of delivery.

The specific aims of this study were as follows:

1. To evaluate the relationship between markers of EED in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.

2. To evaluate the relationship aflatoxin B1 exposure in pregnancy and negative birth outcomes, including low birth weight, stunting at birth, small head circumference, and premature delivery.

Conditions

Birth Weight; Pregnancy Preterm; Aflatoxins Toxicity; Inflammatory Response

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Pregnant Women in Mukono Uganda

Single-group study

Exposures of interest: Maternal EED and Aflatoxin Exposure

Intervention Type: OTHER

Maternal EED, measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS); Maternal aflatoxin exposure, measured via serum concentration of AFB1-lysine adduct

Interventions

Exposures of interest: Maternal EED and Aflatoxin Exposure

Maternal EED, measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS); Maternal aflatoxin exposure, measured via serum concentration of AFB1-lysine adduct

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Carrying a singleton pregnancy
• 18-45 years old
• Residing within 10 kilometers of Mukono Town

Exclusion Criteria

• Younger than 18 years old or older than 45 years old
• HIV-positive (verified via routine rapid HIV test conducted at first prenatal visit)
• Severely malnourished (defined as BMI <16.0 kg/m^2)
• Severely anemic (defined as Hb <7 g/dl)
• Planning to move away from Mukono District prior to delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Agency for International Development (USAID)

FED

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Tufts University

OTHER

Sponsor Role: lead

Responsible Party

Shibani Ghosh

Adjunct Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shibani Ghosh, PhD

Role: PRINCIPAL_INVESTIGATOR

Tufts University Friedman School of Nutrition Science and Policy

Locations

Mukono Health Center IV

Mukono, , Uganda

Countries

Uganda

Other Identifiers

AID-OAA-L-10-00006

Identifier Type: -

Identifier Source: org_study_id