Clinical Trials Logo

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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03429257
Study type Observational
Source Tufts University
Contact
Status Completed
Phase N/A
Start date February 1, 2017
Completion date December 1, 2017

See also
  Status Clinical Trial Phase
Completed NCT04496154 - Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood N/A
Enrolling by invitation NCT05020210 - Effect of Early Treatment With Sivelestat Sodium in ARDS Patients
Completed NCT04084301 - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury N/A
Completed NCT04597983 - Effect of 8-week Intake of 2S-hesperidin on Performance, Body Composition and Biochemicals Markers in Amateur Cyclists N/A
Not yet recruiting NCT06016023 - Evaluation of Macrophage Inflammatory Protein-1α as a Periodontal Disease Biomarker
Not yet recruiting NCT05990933 - Role of Adrenaline in in the Inflammatory Response in Diabetes N/A
Not yet recruiting NCT04608643 - Inflammatory Markers and Cbc Indices in Severely Malnourished Children
Recruiting NCT01934049 - Postoperative Recovery in Elderly Patients Undergoing Hip Hemi-arthroplasty Phase 4
Recruiting NCT01417923 - The Immune and Clinical Impacts of Vitamin D in Patients With Chronic Musculo-skeletal Pain Phase 4
Terminated NCT01377441 - Effect of Intravenous Ibuprofen on Inflammatory Responses in Patients Undergoing Surgery With General Anesthesia. Phase 4
Completed NCT01301079 - Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia Phase 3
Terminated NCT00578578 - Trial to Study the Effects of Supplementary Omega-3 on Serum C-Reactive Protein Levels Phase 4
Recruiting NCT04611334 - The Effects of HRV Biofeedback on Chronic Kidney Disease Patient. N/A
Recruiting NCT03510702 - SCREENING OF EPIGENETIC BIOMARKERS (miRNAs) IN THE GINGIVAL SULCUS
Completed NCT03445234 - Blueberries, Bananas, Exercise Recovery N/A
Not yet recruiting NCT05754294 - Electric Polarization of Red Blood Cells : A Cohort Study to Assess the Erythrocytes Membrane Integrity Through Charge Conservation, Following Cardiac Surgery.
Not yet recruiting NCT04386525 - Omega 3 and Ischemic Stroke; Fish Oil as an Option Phase 4
Completed NCT04864600 - CANDLE - A Study of Acute Health Effects of Exposure to Particles Generated by Candles N/A
Completed NCT04014439 - Relationship Between NLR and Prealbumin Levels With Diaphragm Thickness
Active, not recruiting NCT03002259 - Dexamethasone for Cardiac Surgery-II Trial Phase 4