ClinicalTrials.gov
ClinicalTrials.gov Menu

Aflatoxin Birth Cohort Study Nepal (AflaCohort) (AflaCohort)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03312049
Recruitment Status : Active, not recruiting
First Posted : October 17, 2017
Last Update Posted : May 1, 2018
Sponsor:
Collaborators:
Helen Keller International
Patan Academy of Health Sciences
Purdue University
Government of Nepal
Nepalgunj Medical College
Information provided by (Responsible Party):
Patrick Webb, Tufts University

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.

Condition or disease
Stunting Birth Weight Birth Length Height for Age Linear Growth Failure

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 1675 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Relationship Between Maternal Exposure to Mycotoxins, Birth Outcomes and Stunting in Infants: A Birth Cohort Study in Nepal
Actual Study Start Date : July 6, 2015
Estimated Primary Completion Date : March 31, 2019
Estimated Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Growth Disorders




Primary Outcome Measures :
  1. Change in Height for Age Z-scores (HAZ) [ Time Frame: Measured at birth and when infant turns 3, 6, 9, 12, 18 and 24 months of age ]
    Height for Age Z-scores based on the World Health Organization's 2006 Child Growth Standards, HAZ < −6 and > 6


Secondary Outcome Measures :
  1. Aflatoxin M1 (breast milk) [ Time Frame: Measured when infant is 3 months of age ]
    High-performance liquid chromatography (HPLC) method used to measure ng aflatoxin M1 per liter of breast milk (ng/L)

  2. Low birth weight [ Time Frame: Measured at birth ]
    < 2500 g

  3. Aflatoxin B1 (serum) [ Time Frame: Measured during pregnancy ]
    High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin

  4. Change in infant aflatoxin B1 [ Time Frame: Measured when infant turns 3, 6, 12 and 18 months of age ]
    High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin

  5. Fumonisin B, Deoxynivalenol (DON) (urine) [ Time Frame: Measured when infant turns 18 months of age ]
    High-performance liquid chromatography (HPLC)

  6. Ochratoxin A (serum) [ Time Frame: Measured when infant turns 18 months of age ]
    High-performance liquid chromatography (HPLC)


Biospecimen Retention:   Samples With DNA
Serum aflatoxin B1-lysine adduct levels Breast milk aflatoxin M1 levels


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   16 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women and adolescent girls
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03312049


Sponsors and Collaborators
Tufts University
Helen Keller International
Patan Academy of Health Sciences
Purdue University
Government of Nepal
Nepalgunj Medical College
Investigators
Principal Investigator: Patrick Webb, PhD Tufts University
Principal Investigator: Kedar P Baral, MD Patan Academy of Health Sciences
Principal Investigator: Shibani Ghosh, PhD Tufts University

Responsible Party: Patrick Webb, Alexander McFarlane Professor of Nutrition, Tufts University
ClinicalTrials.gov Identifier: NCT03312049     History of Changes
Other Study ID Numbers: USAID AID-OAA-G-14-0000
First Posted: October 17, 2017    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Patrick Webb, Tufts University:
Aflatoxin B1
Aflatoxin M1
Aflatoxin
Mycotoxin
Stunting
Linear growth
Pregnancy
Birth outcomes
Nepal

Additional relevant MeSH terms:
Birth Weight
Growth Disorders
Failure to Thrive
Body Weight
Signs and Symptoms
Pathologic Processes