Aflatoxin IngestionMMTNCT03940547
Mycotoxin Mitigation Trial
A study testing Provision of flour and Promotion of flour in people with Aflatoxin Ingestion, run by Cornell University at 1 site in Tanzania.
Trial summary
Multiple observational studies show an association between fetal and post-natal aflatoxin exposure and reduced linear growth. However, the effects of confounding factors such as socio-economic status, food insecurity and nutrient deficiencies due to monotonous diets have not been ruled out. Read more about this study
- Who is it for?
- Ages 6 weeks to 3 months
- Conditions the study is for
- Aflatoxin Ingestion
- What is being tested?
- Provision of flour and Promotion of flour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,842 participants
- Where
- 1 siteTanzania
- Study dates
- 24 Apr 2019to 20 Aug 2021
- Phase
- Interventional
- 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 6 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 1. Babies >6 weeks old and <4 months old, who seek Expanded Program on Immunization (EPI) from a randomized health facility and reside in Kongwa District
- Exclusion Criteria, assessed at recruitment and again at the 6-month visit:
- Babies with disabilities that preclude normal feeding and swallowing
- Refusal to consent to assigned intervention
- An infant who has shown signs of a potential groundnut allergy (assessed the first time mother reports groundnut consumption)
- An infant who is a twin
- If the mother plans to travel for more than 2 months at or after the randomized intervention begins
- If the mother is below 16 years of age
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trial to Establish Causal Linkage Between Mycotoxin Exposure and Child Stunting
Multiple observational studies show an association between fetal and post-natal aflatoxin exposure and reduced linear growth. However, the effects of confounding factors such as socio-economic status, food insecurity and nutrient deficiencies due to monotonous diets have not been ruled out. This trial will quantify the causal role of infant aflatoxin ingestion on post-natal growth by performing a cluster randomized trial in children 6-18 months of age in the Dodoma Region of Tanzania.
All health facilities in one district in Dodoma will be randomized to the control or intervention arm. Infants will be recruited into the study over one year to account for seasonal variation in AF exposure. Both arms will receive infant and young child feeding education, a thermos flask and plastic measuring scoops. The intervention arm will receive a low-aflatoxin pre-blended porridge flour containing maize and groundnut (ratio 4:1 respectively) and low-aflatoxin groundnut flour, whereas in the control arm the same porridge mix will be promoted through education, but acquired by the household. The primary outcome is length-for-age Z-score at 18 months.
Read the detailed description
The objective of this study is to determine the effect of a very low AF complementary feeding intervention on LAZ using a cluster randomized design (CRT), while promoting a nutritionally adequate diet to all infants between 6-18 months of age. The hypothesis is that ingestion of AF can reduce infant length and that a reduction of AF exposure will result in improved length for age z-scores (LAZ). The primary outcome is LAZ, which will be measured at 18 months.
The unit of randomization is government-run health facilities (health centers, dispensaries and hospital, 52 clusters in total) in the Kongwa District. Mothers and infants will be recruited into the trial based on 42 day EPI visit attendance, which has very high (>95%) coverage in Kongwa District. Recruitment of infants will be performed for one complete calendar year capture variability in exposure by season.
Critical to casual inference is the intervention's ability to create a contrast of AF consumption between the control and intervention groups, without creating differential macro- or micro-nutrient intake or differences in feeding and care practices that could affect stunting between arms. To reduce the risk of introducing these biases, the investigators designed the intervention to include: 1) education to improve infant feeding and care practices in both arms, and 2) behavior change communication on the use of blended infant porridge flours in both arms. Participants in the intervention group will receive low-aflatoxin blended infant porridge flour and groundnut flour, made in accordance with Tanzanian food and mycotoxin regulations. Those in the control group will not receive any flour, but will be advised to feed their infants a blend similar in ingredients and ratio to what the intervention group will receive. Both groups will receive a thermos flask to store porridge and a small plastic measuring scoop to measure porridge flour for preparation of the porridge.
The sample size was calculated using a one-sided test of independent sample means, with a standard deviation of 1.2 Z, type I error of 0.05, power of 0.90, design effect of 2.0 and assuming a coefficient of variation of .144 for varying cluster size, based on previous year's data for EPI attendance at 42 days. Given these parameters our total sample size is calculated to be 2,322 (1,161 infants per cluster). Conservatively estimating a 20% loss to follow-up and infant mortality, the total number of infants is 2,787, or 54 infants recruited per health cluster annually or 4.5 infants per cluster per month. Rounding up, 5 infants per cluster each month will be recruited for a total of 3,120 potential infants, recognizing that in approximately 6 of the health facilities, it is unlikely that all 60 infants because of the size of the population served by the facility.
The trial will be conducted in the Kongwa District of Dodoma, Tanzania, where the investigators have performed formative research (Protocol Identification#: 1703007043) and confirmed AF contamination in local foods, primarily groundnuts, and that infants are exposed to aflatoxin. The frequency and level of exposure is similar in range to the West African observational studies. Kongwa District is a good location to perform this study, as exposure is high enough to be suspected of contributing to stunting, but low enough as to not cause aflatoxicosis.
NOTE: Data collection was stopped between April 9 and June 8, 2020 due to the SARS-CoV-2 outbreak, in accordance with the guidance of the Tanzanian National Institute for Medical Research. The delivery of the intervention continued during this time.
- Conditions
- Aflatoxin Ingestion
- Being tested
- Provision of flour, Promotion of flour
- Keywords
- Aflatoxin ingestion, Growth, Stunting, nutritional
- Medical subject headings
- Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Provision of flourOther
Infant and young child feeding education and provision of low AF porridge and groundnut flours from 6-18 months
Promotion of flourOther
Infant and young child feeding education and promotion of porridge and groundnut flours from 6-18 months
| Study group | Role | What they receive |
|---|---|---|
| Experimental - provision of flour | Experimental | This arm will receive infant and young child feeding education performed by community health workers and very-low aflatoxin (AF) pre-blended porridge flour, ratio 4:1 maize to groundnut. Provision of this pre-blended flour will be 50 grams/day for 6-8 month olds, 60/day grams for 9-11 months and 75 grams/day for 12-18 month olds (with 10-15 grams added per day to account for any loss). Participants will also receive 1 kg of low-AF groundnut flour each month for 6-18 month olds. Finally, participants will receive a thermos flask to hygienically store porridge and a plastic scoop to measure appropriate amount of porridge flour each day. Receives: Other: Provision of flour |
| Control - promotion of flour | Active comparator | This arm will receive infant and young child feeding education performed by community health workers and promotion of porridge made from maize and groundnut to match what is provided to the intervention arm. Participants will also receive a thermos flask to hygienically store porridge and a plastic scoop to measure appropriate amount of porridge flour each day. Receives: Other: Promotion of flour |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear growth
Length for age Z score
Measured: 18 months
Secondary outcomes (8)
Linear growth
Length for age Z score
Measured: 12 months
Prevalence of stunting
Prevalence of stunting (<-2 LAZ)
Measured: 12 and 18 months
Ponderal growth
Weight for age Z score
Measured: 12 and 18 months
Prevalence of underweight
Prevalence of underweight (<-2 WAZ)
Measured: 12 and 18 months
Concentration of urinary biomarker
Concentration of aflatoxin M1 (AFM1) urinary biomarker
Measured: 9, 12, 15, 18 months
Concentration of AF blood biomarker
Concentration of AF blood biomarker AF-alb
Measured: 12 and 18 months
Middle-upper-arm circumference (MUAC)
Middle-upper-arm circumference Z score
Measured: 12 and 18 months in full sample; 9, 12, 15, 18 months in sub-samples
Head circumference
Head-circumference-for-age Z score
Measured: 12 and 18 months in full sample; 9, 12, 15, 18 months in sub-samples
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start24 Apr 2019
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Aflatoxin IngestionStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,842 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Maryland, The Nelson Mandela African Institution of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Rebecca J Stoltzfus, PhD, Principal investigator, Cornell UniversityRebecca J Nelson, PhD, Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940547
- Sponsor's protocol ID
- 1809008284
- Acronym
- MMT
- Status last verified
- Jan 2022
- First submitted
- 23 Apr 2019
- Last updated
- 7 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data that underlie the results related to the primary outcome will be made publicly available in a public data repository following the publication of the primary outcome paper, ideally 12 months following the end of data collection. Data that underlie the results for all secondary outcomes will also be placed in a public repository following the publication of these papers.
Publications
Phillips E, Ngure FM, Kassim N, Turner PC, Makule E, Smith LE, Makori N, Cramer B, Humpf HU, Nelson RJ, Stoltzfus RJ. The effect of an intervention to reduce aflatoxin consumption from 6 to 18 mo of age on length-for-age z-scores in rural Tanzania: a cluster-randomized trial. Am J Clin Nutr. 2025 Feb;121(2):333-342. doi: 10.1016/j.ajcnut.2024.11.022. Epub 2024 Nov 26.
PubMed 39608608Phillips E, Ngure F, Smith LE, Makule E, Turner PC, Nelson R, Kimanya M, Stoltzfus R, Kassim N. Protocol for the trial to establish a causal linkage between mycotoxin exposure and child stunting: a cluster randomized trial. BMC Public Health. 2020 May 1;20(1):598. doi: 10.1186/s12889-020-08694-6.
PubMed 32357944
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Establish Causal Linkage Between Mycotoxin Exposure and Child Stunting
- ClinicalTrials.gov ID
- NCT03940547
- Acronym / sponsor ID
- MMT / 1809008284
- Conditions
- Aflatoxin Ingestion
- Keywords
- Aflatoxin ingestion, Growth, Stunting, nutritional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,842 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Collaborators
- University of Maryland, The Nelson Mandela African Institution of Science and Technology
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 7 May 2019 (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.
Multiple observational studies show an association between fetal and post-natal aflatoxin exposure and reduced linear growth. However, the effects of confounding factors such as socio-economic status, food insecurity and nutrient deficiencies due to monotonous diets have not been ruled out. This trial will quantify the causal role of infant aflatoxin ingestion on post-natal growth by performing a cluster randomized trial in children 6-18 months of age in the Dodoma Region of Tanzania.
All health facilities in one district in Dodoma will be randomized to the control or intervention arm. Infants will be recruited into the study over one year to account for seasonal variation in AF exposure. Both arms will receive infant and young child feeding education, a thermos flask and plastic measuring scoops. The intervention arm will receive a low-aflatoxin pre-blended porridge flour containing maize and groundnut (ratio 4:1 respectively) and low-aflatoxin groundnut flour, whereas in the control arm the same porridge mix will be promoted through education, but acquired by the household. The primary outcome is length-for-age Z-score at 18 months.
Detailed description
The objective of this study is to determine the effect of a very low AF complementary feeding intervention on LAZ using a cluster randomized design (CRT), while promoting a nutritionally adequate diet to all infants between 6-18 months of age. The hypothesis is that ingestion of AF can reduce infant length and that a reduction of AF exposure will result in improved length for age z-scores (LAZ). The primary outcome is LAZ, which will be measured at 18 months.
The unit of randomization is government-run health facilities (health centers, dispensaries and hospital, 52 clusters in total) in the Kongwa District. Mothers and infants will be recruited into the trial based on 42 day EPI visit attendance, which has very high (>95%) coverage in Kongwa District. Recruitment of infants will be performed for one complete calendar year capture variability in exposure by season.
Critical to casual inference is the intervention's ability to create a contrast of AF consumption between the control and intervention groups, without creating differential macro- or micro-nutrient intake or differences in feeding and care practices that could affect stunting between arms. To reduce the risk of introducing these biases, the investigators designed the intervention to include: 1) education to improve infant feeding and care practices in both arms, and 2) behavior change communication on the use of blended infant porridge flours in both arms. Participants in the intervention group will receive low-aflatoxin blended infant porridge flour and groundnut flour, made in accordance with Tanzanian food and mycotoxin regulations. Those in the control group will not receive any flour, but will be advised to feed their infants a blend similar in ingredients and ratio to what the intervention group will receive. Both groups will receive a thermos flask to store porridge and a small plastic measuring scoop to measure porridge flour for preparation of the porridge.
The sample size was calculated using a one-sided test of independent sample means, with a standard deviation of 1.2 Z, type I error of 0.05, power of 0.90, design effect of 2.0 and assuming a coefficient of variation of .144 for varying cluster size, based on previous year's data for EPI attendance at 42 days. Given these parameters our total sample size is calculated to be 2,322 (1,161 infants per cluster). Conservatively estimating a 20% loss to follow-up and infant mortality, the total number of infants is 2,787, or 54 infants recruited per health cluster annually or 4.5 infants per cluster per month. Rounding up, 5 infants per cluster each month will be recruited for a total of 3,120 potential infants, recognizing that in approximately 6 of the health facilities, it is unlikely that all 60 infants because of the size of the population served by the facility.
The trial will be conducted in the Kongwa District of Dodoma, Tanzania, where the investigators have performed formative research (Protocol Identification#: 1703007043) and confirmed AF contamination in local foods, primarily groundnuts, and that infants are exposed to aflatoxin. The frequency and level of exposure is similar in range to the West African observational studies. Kongwa District is a good location to perform this study, as exposure is high enough to be suspected of contributing to stunting, but low enough as to not cause aflatoxicosis.
NOTE: Data collection was stopped between April 9 and June 8, 2020 due to the SARS-CoV-2 outbreak, in accordance with the guidance of the Tanzanian National Institute for Medical Research. The delivery of the intervention continued during this time.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental - provision of flour | Experimental | Other: Provision of flourThis arm will receive infant and young child feeding education performed by community health workers and very-low aflatoxin (AF) pre-blended porridge flour, ratio 4:1 maize to groundnut. Provision of this pre-blended flour will be 50 grams/day for 6-8 month olds, 60/day grams for 9-11 months and 75 grams/day for 12-18 month olds (with 10-15 grams added per day to account for any loss). Participants will also receive 1 kg of low-AF groundnut flour each month for 6-18 month olds. Finally, participants will receive a thermos flask to hygienically store porridge and a plastic scoop to measure appropriate amount of porridge flour each day. |
| Control - promotion of flour | Active comparator | Other: Promotion of flourThis arm will receive infant and young child feeding education performed by community health workers and promotion of porridge made from maize and groundnut to match what is provided to the intervention arm. Participants will also receive a thermos flask to hygienically store porridge and a plastic scoop to measure appropriate amount of porridge flour each day. |
Who may qualify
- Ages
- 6 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 1. Babies >6 weeks old and <4 months old, who seek Expanded Program on Immunization (EPI) from a randomized health facility and reside in Kongwa District
- Babies with disabilities that preclude normal feeding and swallowing
- Refusal to consent to assigned intervention
- An infant who has shown signs of a potential groundnut allergy (assessed the first time mother reports groundnut consumption)
- An infant who is a twin
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Provision of flourInfant and young child feeding education and provision of low AF porridge and groundnut flours from 6-18 months | Other | Experimental - provision of flour |
| Promotion of flourInfant and young child feeding education and promotion of porridge and groundnut flours from 6-18 months | Other | Control - promotion of flour |
Primary outcome
Linear growth
Time frame: 18 months
Length for age Z score
8 secondary outcomes
Linear growth
Time frame: 12 months
Prevalence of stunting
Time frame: 12 and 18 months
Ponderal growth
Time frame: 12 and 18 months
Prevalence of underweight
Time frame: 12 and 18 months
Concentration of urinary biomarker
Time frame: 9, 12, 15, 18 months
Concentration of AF blood biomarker
Time frame: 12 and 18 months
Middle-upper-arm circumference (MUAC)
Time frame: 12 and 18 months in full sample; 9, 12, 15, 18 months in sub-samples
Head circumference
Time frame: 12 and 18 months in full sample; 9, 12, 15, 18 months in sub-samples
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 7 Feb 2022.
- Derived from this study: PubMed 39608608Phillips E, Ngure FM, Kassim N, Turner PC, Makule E, Smith LE, Makori N, Cramer B, Humpf HU, Nelson RJ, Stoltzfus RJ. The effect of an intervention to reduce aflatoxin consumption from 6 to 18 mo of age on length-for-age z-scores in rural Tanzania: a cluster-randomized trial. Am J Clin Nutr. 2025 Feb;121(2):333-342. doi: 10.1016/j.ajcnut.2024.11.022. Epub 2024 Nov 26.
- Derived from this study: PubMed 32357944Phillips E, Ngure F, Smith LE, Makule E, Turner PC, Nelson R, Kimanya M, Stoltzfus R, Kassim N. Protocol for the trial to establish a causal linkage between mycotoxin exposure and child stunting: a cluster randomized trial. BMC Public Health. 2020 May 1;20(1):598. doi: 10.1186/s12889-020-08694-6.
- Individual participant dataSharing planned: Yes. De-identified participant data that underlie the results related to the primary outcome will be made publicly available in a public data repository following the publication of the primary outcome paper, ideally 12 months following the end of data collection. Data that underlie the results for all secondary outcomes will also be placed in a public repository following the publication of these papers.
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.
Rebecca J Stoltzfus, PhD principal investigator
Cornell University
Rebecca J Nelson, PhD principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Provision of flour and Promotion of flour in people with Aflatoxin Ingestion, run by Cornell University at 1 site in Tanzania.
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 0 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 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Linear growth (time frame: 18 months). 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 NCT03940547, which also lists 2 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 7 Feb 2022.