KwashiorkorNCT01395381
Effectiveness of Oral Albendazole in the Treatment of Severe Acute Malnutrition
A study testing Albendazole in people with Kwashiorkor and Marasmus, run by Washington University School of Medicine at 1 site in Malawi.
Trial summary
The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without… Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Kwashiorkor, Marasmus
- What is being tested?
- Albendazole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteMalawi
- Study dates
- Jan 2013to Jan 2014
- 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 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12-59 months old
- Kwashiorkor and/or Marasmus
- Qualified for home-based therapeutic feeding with RUTF
Who cannot join
- Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
- Unable to consume test-dose of RUTF in clinic
- Parent refusal to participate and return for follow-up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children
The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.
- Conditions
- Kwashiorkor, Marasmus
- Being tested
- Placebo, Albendazole
- Medical subject headings
- Kwashiorkor, Protein-Energy Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
placebo given once
AlbendazoleDrug
single dose albendazole given at the time of enrollment
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Albendazole | Experimental | Not described Receives: Drug: Albendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
nutritional recovery
Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema
Measured: 12 weeks
mortality
Measured: 12 weeks
Secondary outcomes (2)
malnutrition relapse
acute malnutrition, either moderate (WHZ < -2) or severe (WHZ < -3 and/or bipedal pitting edema)
Measured: 6 months
height and weight gain
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJan 2013
- Primary completionJan 2014 (estimated)
Why it stopped: not funded
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KwashiorkorStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Responsible party
- Sponsor
- Investigators
- Mark J Manary, MD, Principal investigator, University of MalawiKenneth Maleta, MBBS PhD, Principal investigator, University of MalawiIndi Trehan, MD MPH DTM&H, Study director, University of Malawi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395381
- Sponsor's protocol ID
- MJM-albendazole
- Status last verified
- Jan 2014
- First submitted
- 1 Jul 2011
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Benefit of Antihelminthic Therapy in the Community-Based Treatment of Severe Acute Malnutrition in Malawian Children
- ClinicalTrials.gov ID
- NCT01395381
- Acronym / sponsor ID
- MJM-albendazole
- Conditions
- Kwashiorkor, Marasmus
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: not funded
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Kamuzu University of Health Sciences
- Study start
- Jan 2013
- Primary completion
- Jan 2014 (estimated)
- First posted
- 15 Jul 2011 (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.
The benefit of anti-worm therapy as part of the case management of severe acute malnutrition (SAM) in the outpatient setting has not previously been studied. This study will compare recovery rates of children with SAM treated in the community with locally-produced ready-to-use therapeutic food (RUTF) with and without prescribed albendazole as part of their case management.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo |
| Albendazole | Experimental | Drug: Albendazole |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 12-59 months old
- Kwashiorkor and/or Marasmus
- Qualified for home-based therapeutic feeding with RUTF
Key exclusion criteria (3 listed)
- Obvious congenital or other malformation that makes child a poor candidate for feeding with RUTF
- Unable to consume test-dose of RUTF in clinic
- Parent refusal to participate and return for follow-up
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 |
|---|---|---|
| Placeboplacebo given once | Drug | Placebo |
| Albendazolesingle dose albendazole given at the time of enrollment | Drug | Albendazole |
Primary outcome
nutritional recovery
Time frame: 12 weeks
Weight-for-Height Z-score (WHZ) > -2 without bipedal pitting edema
mortality
Time frame: 12 weeks
2 secondary outcomes
malnutrition relapse
Time frame: 6 months
height and weight gain
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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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
University of Malawi
Kenneth Maleta, MBBS PhD principal investigator
University of Malawi
Indi Trehan, MD MPH DTM&H study director
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 in people with Kwashiorkor and Marasmus, 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 3 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: withdrawn, as of the sponsor's last update on 28 Jan 2014. 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 was withdrawn before enrolling participants, so there are no results.
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?
nutritional recovery (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?
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 28 Jan 2014.