Environmental EnteropathyNCT02253095
Combined Package of Interventions for Environmental Enteropathy
A study testing Albendazole, Zinc and Multiple Micronutrient Supplement in people with Environmental Enteropathy, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children. Read more about this study
- Who is it for?
- Ages 12 to 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Environmental Enteropathy
- What is being tested?
- Albendazole, Zinc and Multiple Micronutrient Supplement
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 253 participants
- Where
- 1 siteMalawi
- Study dates
- Oct 2014to Apr 2015
- 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 12 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children residing in catchment area of Limela, Machinga District, Malawi
- aged 12-35 months
- youngest eligible child in each household
Who cannot join
- severe acute malnutrition
- severe chronic illness
- children unable to drink 20 mL of dual sugar solution
- children in need of acute medical treatment for illness or injury at time of enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
- Conditions
- Environmental Enteropathy
- Being tested
- Albendazole, Zinc, Multiple Micronutrient Supplement, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlbendazoleDrug
ZincDietary supplement
Multiple Micronutrient SupplementDietary supplement
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Multiple Intervention Arm | Experimental | single dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients Receives: Drug: Albendazole; Dietary Supplement: Zinc; Dietary Supplement: Multiple Micronutrient Supplement |
| Placebo | Placebo comparator | three placebos Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 12 weeks
Dual Sugar Absorption Test
lactulose-mannitol ratio in urine
Measured: 24 weeks
Secondary outcomes (4)
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 12 weeks
Lactulose Excretion
percentage of ingested lactulose excreted in urine
Measured: 24 weeks
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 12 weeks
Mannitol Excretion
percentage of ingested mannitol excreted in urine
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Environmental EnteropathyStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malawi
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, Washington University in St. Louis; University of MalawiChrissie Thakwalakwa, PhD, Study director, University of MalawiIndi Trehan, MD MPH DTM&H, Study director, Washington University in St. Louis; University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253095
- Sponsor's protocol ID
- EE-zinc-alb-micronut
- Status last verified
- Jun 2015
- First submitted
- 26 Sep 2014
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Wang AZ, Shulman RJ, Crocker AH, Thakwalakwa C, Maleta KM, Devaraj S, Manary MJ, Trehan I. A Combined Intervention of Zinc, Multiple Micronutrients, and Albendazole Does Not Ameliorate Environmental Enteric Dysfunction or Stunting in Rural Malawian Children in a Double-Blind Randomized Controlled Trial. J Nutr. 2017 Jan;147(1):97-103. doi: 10.3945/jn.116.237735. Epub 2016 Nov 2.
PubMed 27807040
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double Blind, Placebo Controlled Trial Comparing the Impact of a Combined Package of Interventions vs Placebo in the Treatment of Sub-clinical Environmental Enteropathy in Rural Malawian Children
- ClinicalTrials.gov ID
- NCT02253095
- Acronym / sponsor ID
- EE-zinc-alb-micronut
- Conditions
- Environmental Enteropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 253 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- University of Malawi
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 1 Oct 2014 (estimated)
- 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.
Randomized, double-blind, placebo controlled trial of a combined intervention of zinc, albendazole, and multiple micronutrients in improving environmental enteropathy in Malawian children.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Intervention Arm | Experimental | Drug: Albendazole, Dietary Supplement: Zinc, Dietary Supplement: Multiple Micronutrient Supplementsingle dose albendazole, two weeks of zinc, 24 weeks of multiple micronutrients |
| Placebo | Placebo comparator | Drug: Placebothree placebos |
Who may qualify
- Ages
- 12 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children residing in catchment area of Limela, Machinga District, Malawi
- aged 12-35 months
- youngest eligible child in each household
Key exclusion criteria (4 listed)
- severe acute malnutrition
- severe chronic illness
- children unable to drink 20 mL of dual sugar solution
- children in need of acute medical treatment for illness or injury at time of enrollment
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 |
|---|---|---|
| Albendazole | Drug | Multiple Intervention Arm |
| Zinc | Dietary supplement | Multiple Intervention Arm |
| Multiple Micronutrient Supplement | Dietary supplement | Multiple Intervention Arm |
| Placebo | Drug | Placebo |
Primary outcome
Dual Sugar Absorption Test
Time frame: 12 weeks
lactulose-mannitol ratio in urine
Dual Sugar Absorption Test
Time frame: 24 weeks
lactulose-mannitol ratio in urine
4 secondary outcomes
Lactulose Excretion
Time frame: 12 weeks
Lactulose Excretion
Time frame: 24 weeks
Mannitol Excretion
Time frame: 12 weeks
Mannitol Excretion
Time frame: 24 weeks
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 3 Jun 2015.
- Derived from this study: PubMed 27807040Wang AZ, Shulman RJ, Crocker AH, Thakwalakwa C, Maleta KM, Devaraj S, Manary MJ, Trehan I. A Combined Intervention of Zinc, Multiple Micronutrients, and Albendazole Does Not Ameliorate Environmental Enteric Dysfunction or Stunting in Rural Malawian Children in a Double-Blind Randomized Controlled Trial. J Nutr. 2017 Jan;147(1):97-103. doi: 10.3945/jn.116.237735. Epub 2016 Nov 2.
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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.
Mark J Manary, MD principal investigator
Washington University in St. Louis; University of Malawi
Chrissie Thakwalakwa, PhD study director
University of Malawi
Indi Trehan, MD MPH DTM&H study director
Washington University in St. Louis; University of Malawi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Albendazole, Zinc and Multiple Micronutrient Supplement in people with Environmental Enteropathy, run by Washington University School of Medicine at 1 site in Malawi.
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 3 inclusion and 4 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 3 Jun 2015. 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 Malawi. 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. Some participants in this study may receive a placebo. 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?
Dual Sugar Absorption Test (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02253095, which also lists 1 linked publication.
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 3 Jun 2015.