StuntingAflaCohortNCT03312049
Aflatoxin Birth Cohort Study Nepal (AflaCohort)
An observational study of Stunting and Birth Weight, run by Tufts University.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stunting, Birth Weight, Birth Length
- How many people
- 1,675 participants
- Where
- No sites listed yet
- Study dates
- 6 Jul 2015to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 49 years
- Women only
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
About this study
Official title: Relationship Between Maternal Exposure to Mycotoxins, Birth Outcomes and Stunting in Infants: A Birth Cohort Study in Nepal
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:
- To examine the relationship of maternal mycotoxin exposure in pregnancy and birth outcomes, including infant birth weight.
- To examine the relationship of exposure to mycotoxin of infants through breast milk and their linear growth.
- To examine the relationship of exposure to mycotoxin through complementary feeding and linear growth.
- 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:
- 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.
- 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.
- 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.
- 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.
- Knowledge of the problem of food-borne contaminants is associated with improved food processing and storage practices.
- Conditions
- 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
- Medical subject headings
- Growth Disorders, Birth Weight, Failure to Thrive
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Measured at birth and when infant turns 3, 6, 9, 12, 18 and 24 months of age
Secondary outcomes (6)
Aflatoxin M1 (breast milk)
High-performance liquid chromatography (HPLC) method used to measure ng aflatoxin M1 per liter of breast milk (ng/L)
Measured: Measured when infant is 3 months of age
Low birth weight
< 2500 g
Measured: Measured at birth
Aflatoxin B1 (serum)
High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin
Measured: Measured during pregnancy
Change in infant aflatoxin B1
High-performance liquid chromatography (HPLC) method used to measure pg aflatoxin B1-lysine adducts per mg albumin
Measured: Measured when infant turns 3, 6, 12 and 18 months of age
Fumonisin B, Deoxynivalenol (DON) (urine)
High-performance liquid chromatography (HPLC)
Measured: Measured when infant turns 18 months of age
Ochratoxin A (serum)
High-performance liquid chromatography (HPLC)
Measured: Measured when infant turns 18 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2017
- Study start6 Jul 2015
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StuntingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,675 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Collaborators
- Helen Keller International, Patan Academy of Health Sciences, Purdue University, Government of Nepal, Nepalgunj Medical College
- Responsible party
- Principal investigator, Patrick Webb, Tufts University
- Investigators
- Patrick Webb, PhD, Principal investigator, Tufts UniversityKedar P Baral, MD, Principal investigator, Patan Academy of Health SciencesShibani Ghosh, PhD, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03312049
- Sponsor's protocol ID
- USAID AID-OAA-G-14-0000
- Acronym
- AflaCohort
- Status last verified
- May 2019
- First submitted
- 11 Sep 2017
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 35444268Andrews-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 33677532Andrews-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
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Maternal Exposure to Mycotoxins, Birth Outcomes and Stunting in Infants: A Birth Cohort Study in Nepal
- ClinicalTrials.gov ID
- NCT03312049
- Acronym / sponsor ID
- AflaCohort / USAID AID-OAA-G-14-0000
- Conditions
- Stunting, Birth Weight, Birth Length, Height for Age, Linear Growth Failure
- Keywords
- Aflatoxin B1, Aflatoxin M1, Aflatoxin, Mycotoxin, Stunting, Linear growth, Pregnancy, Birth outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,675 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Collaborators
- Helen Keller International, Patan Academy of Health Sciences, Purdue University, Government of Nepal, Nepalgunj Medical College
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 17 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To examine the relationship of maternal mycotoxin exposure in pregnancy and birth outcomes, including infant birth weight.
- To examine the relationship of exposure to mycotoxin of infants through breast milk and their linear growth.
- To examine the relationship of exposure to mycotoxin through complementary feeding and linear growth.
- 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:
- 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.
- 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.
- 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.
- 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.
- Knowledge of the problem of food-borne contaminants is associated with improved food processing and storage practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (14 listed)
- Severely malnourished mother <17.5 cm
- Severely anemic mother hemoglobin<7 g/dL
- Pregnancy induced hypertension
- Congenital anomalies
- Very low birth weight <1500 g
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Aflatoxin M1 (breast milk)
Time frame: Measured when infant is 3 months of age
Low birth weight
Time frame: Measured at birth
Aflatoxin B1 (serum)
Time frame: Measured during pregnancy
Change in infant aflatoxin B1
Time frame: Measured when infant turns 3, 6, 12 and 18 months of age
Fumonisin B, Deoxynivalenol (DON) (urine)
Time frame: Measured when infant turns 18 months of age
Ochratoxin A (serum)
Time frame: Measured when infant turns 18 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Derived from this study: PubMed 35444268Lamichhane 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.
- Derived from this study: PubMed 33677532Andrews-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.
- Derived from this study: PubMed 31198947Andrews-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
Questions about this trial
What is this clinical trial studying?
An observational study of Stunting and Birth Weight, run by Tufts University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03312049, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.