Aflatoxin Birth Cohort Study Nepal (AflaCohort) (AflaCohort)
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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 |
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Recruitment Status :
Completed
First Posted : October 17, 2017
Last Update Posted : May 10, 2019
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| Tracking Information | ||||||||||
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| First Submitted Date | September 11, 2017 | |||||||||
| First Posted Date | October 17, 2017 | |||||||||
| Last Update Posted Date | May 10, 2019 | |||||||||
| Actual Study Start Date | July 6, 2015 | |||||||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures |
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
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| Original Primary Outcome Measures |
Change in stunting [ Time Frame: Measured at birth and when infant turns 3, 6, 9 and 12 months of age ] Height for Age Z-scores
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| Change History | ||||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title | Aflatoxin Birth Cohort Study Nepal (AflaCohort) | |||||||||
| Official Title | Relationship Between Maternal Exposure to Mycotoxins, Birth Outcomes and Stunting in Infants: A Birth Cohort Study in Nepal | |||||||||
| 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. | |||||||||
| 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:
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:
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | |||||||||
| Biospecimen | Retention: Samples With DNA Description: Serum aflatoxin B1-lysine adduct levels Breast milk aflatoxin M1 levels
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| 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. | |||||||||
| Condition |
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| Intervention | Not Provided | |||||||||
| Study Groups/Cohorts | Not Provided | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
1675 | |||||||||
| Original Actual Enrollment | Same as current | |||||||||
| Actual Study Completion Date | March 31, 2019 | |||||||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 16 Years to 49 Years (Child, Adult) | |||||||||
| Accepts Healthy Volunteers | Yes | |||||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries | Not Provided | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number | NCT03312049 | |||||||||
| Other Study ID Numbers | USAID AID-OAA-G-14-0000 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Patrick Webb, Tufts University | |||||||||
| Original Responsible Party | Same as current | |||||||||
| Current Study Sponsor | Tufts University | |||||||||
| Original Study Sponsor | Same as current | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Tufts University | |||||||||
| Verification Date | May 2019 | |||||||||