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CompletedNCT03312049AflaCohortUpdated May 10, 2019

Aflatoxin Birth Cohort Study Nepal (AflaCohort)

An observational study in Stunting, Birth Weight and Birth Length, sponsored by Tufts University. Completed. Open to female participants aged 16 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-10.

Sponsored by Tufts University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,675
Ages
16 Years to 49 Years
Sex
Female
01

Study 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.

Read the detailed description

In 2012, a research prioritization meeting organized by IFPRI and the Bill and Melinda Gates Foundation on food-borne toxins concluded, "While there is solid association of stunting with exposure to mycotoxins, the causality has not been proven and the percentage of stunting attributable to mycotoxins in general or to specific mycotoxins is not known." (IFPRI/BMGF 2012) In other words, the extent of the problem, although widely suspected, has been poorly documented and the biological mechanisms thought to be involved remain poorly understood.

To contribute to a better understanding of the mycotoxin-stunting relationship, the Feed the Future Feed the Future Nutrition Innovation Lab-Asia proposes to explore the impact of mycotoxins, with a focus on mycotoxins on child nutrition in Nepal. Through its PoSHAN study, the Nutrition Innovation Lab-Asia is currently undertaking research in Nepal in collaboration with the Child Health Division of the Ministry of Health and Population and multiple local partners on how investments in agriculture can achieve significant impacts on maternal and child nutrition, and on demonstrating how large-scale programs best incorporate such evidence into cost-effective multi-sectoral interventions. Adding a study component on food safety (mycotoxin contamination of the food supply) will significantly enhance our understanding of nutrition outcomes linked to investments in agriculture. As noted by participants of the IFPRI/BMGF (2012) meeting, "only 35% of stunting of children can be attributed to known factors". This leaves room for research to uncover other suspected contributors to the world's huge nutrition problems, which could then lead testable recommendations for innovative interventions to address newly identified factors. The team will assess current mycotoxin risk so that potential mitigation strategies can be developed.

Given the significant statistical associations shown between mycotoxin exposure in children and height gain in infants and young children, the Nutrition Innovation Lab-Asia will undertake an mycotoxin birth cohort study to further the understanding of the causal relationship between past and current mycotoxin exposure (maternal and infant), birth outcomes and length-for-age in Nepali infants and young children. The study will also seek to validate the use of low cost data collection methods (e.g. dried blood spots versus venous blood samples) for mycotoxin analysis.

The specific aims of this study are:

  1. To examine the relationship of maternal mycotoxin exposure in pregnancy and birth outcomes, including infant birth weight.
  2. To examine the relationship of exposure to mycotoxin of infants through breast milk and their linear growth.
  3. To examine the relationship of exposure to mycotoxin through complementary feeding and linear growth.
  4. To enumerate the relative contributions of maternal and infant mycotoxin exposures in impairing linear growth, controlling for other potential explanatory factors.

Controlling for factors such as diet, maternal education, maternal height and BMI, household socio-economic status, infections and inflammation, and other elements such as storage patterns, knowledge of food contaminants and mitigation practices, the specific hypotheses of this study are:

  1. There is an incremental effect of in utero, lactation and complementary feeding mycotoxin exposures on rate of length gain and stunting outcomes for age Z-scores in children at 2 year of age.
  2. Maternal exposure to mycotoxins will be significant predictor of birth weight in infants, thereby being a significant contributor to the burden of stunting at 2 years of age.
  3. Exposure to mycotoxins through breast milk before 6 months of age along with continued exposure through both breast milk and complementary foods (after 6 months of age) is a significant contributor to the burden of stunting at 2 years of age.
  4. Improper farm management, food processing and storage practices are significantly related to higher levels of serum mycotoxins in the blood of mothers and their children.
  5. Knowledge of the problem of food-borne contaminants is associated with improved food processing and storage practices.
02

Conditions studied

  • 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
03

In context

Growth Disorders

227 studies on the registry are indexed under Growth Disorders; 25 are open to participants now.

This study's enrollment of 1,675 is above the median of 231 across 78 observational studies indexed under Growth Disorders.

Browse Growth Disorders studies →

Lead sponsor

Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 49 Years
Sexes eligible
Female
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 herself or through a legal guardian
  • Live Birth
  • Single Birth

Exclusion criteria

Exclusion Criteria:

  • Severely malnourished mother \<17.5 cm
  • Severely anemic mother \<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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,675 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

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

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

Secondary outcomes

  1. Aflatoxin M1 (breast milk)

    High-performance liquid chromatography (HPLC) method used to measure ng aflatoxin M1 per liter of breast milk (ng/L)

    Time frame: Measured when infant is 3 months of age

  2. Low birth weight

    \< 2500 g

    Time frame: Measured at birth

  3. Aflatoxin B1 (serum)

    High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin

    Time frame: Measured during pregnancy

  4. Change in infant aflatoxin B1

    High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin

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

  5. Fumonisin B, Deoxynivalenol (DON) (urine)

    High-performance liquid chromatography (HPLC)

    Time frame: Measured when infant turns 18 months of age

  6. Ochratoxin A (serum)

    High-performance liquid chromatography (HPLC)

    Time frame: Measured when infant turns 18 months of age

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 35444268 ↗
  • 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. PubMed 33677532 ↗
  • 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. PubMed 31198947 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2015 to primary completion in Mar 2019, 44 months.

Of 42 observational studies under Growth Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's 44 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Oct 17, 2017
StartActual
Jul 6, 2015
Primary completionActual
Mar 31, 2019
CompletionActual
Mar 31, 2019
Last update
May 10, 2019
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03312049
Lead sponsor
Tufts University
Collaborators
Helen Keller International, Patan Academy of Health Sciences, Purdue University, Government of Nepal, Nepalgunj Medical College
Responsible party
Patrick Webb (Alexander McFarlane Professor of Nutrition, Tufts University) — Principal investigator
First posted
Oct 17, 2017
Start date
Jul 6, 2015
Primary completion
Mar 31, 2019
Completion
Mar 31, 2019
Last update
May 10, 2019

Study contacts

Patrick Webb, PhD
principal investigator · Tufts University
Kedar P Baral, MD
principal investigator · Patan Academy of Health Sciences
Shibani Ghosh, PhD
principal investigator · Tufts University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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