Maternal EED and Aflatoxin Birth Outcomes Study Uganda

Inflammatory Response Clinical Trial

Official title:

Association Among Maternal Environmental Enteric Dysfunction, Aflatoxin Exposure, and Birth Outcomes: A Prospective Cohort Study in Mukono, Uganda

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03429257
• Other study ID #: AID-OAA-L-10-00006
• Status: Completed
• Phase: N/A
• First received: February 5, 2018
• Last updated: February 5, 2018
• Start date: February 1, 2017
• Est. completion date: December 1, 2017

Study information

• Verified date: February 2018
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: December 1, 2017
• Est. primary completion date: December 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Aflatoxins Toxicity
• Birth Weight
• Inflammatory Response
• Pregnancy Preterm

Intervention

Other:
• 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

Locations

Country	Name	City	State
Uganda	Mukono Health Center IV	Mukono

Sponsors (3)

Lead Sponsor	Collaborator
Tufts University	Harvard School of Public Health, United States Agency for International Development (USAID)

Country where clinical trial is conducted

Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Birth Weight	Low birth weight < 2500 grams	Measured within 48 hours of delivery
Primary	Infant Birth Length		Measured within 48 hours of delivery
Primary	Infant Gestational Age at Birth	Preterm birth <37 weeks gestation	Measured within 48 hours of delivery
Primary	Infant Head Circumference		Measured within 48 hours of delivery