WastingPhase 2NCT01898871
Effectiveness of Nutritional Products to Treat Moderate Acute Malnutrition
A Phase 2 study testing A daily ration of 40 kcal/kg of body weight during 56 days in people with Wasting and Moderate Acute Malnutrition, run by Centre for Food and Nutrition Research, Yaounde at 2 sites in Cameroon.
Trial summary
The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Wasting, Moderate Acute Malnutrition
- What is being tested?
- A daily ration of 40 kcal/kg of body weight during 56 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesCameroon
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 2
- 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
- Children aged 6-59 month
- Weight-for-height between -3 and -2 z-scores without edema
- Good appetite
- Stable clinical conditions
Who cannot join
- Weight-for-Height Z-score < -3
- Presence of bilateral pitting edema
- Unstable clinical conditions
- Not showing appetite
Trial locations and contacts
2 sites in 1 country.
Cameroon2 sites
Evodoula Health District
Évodoula
Biyem Assi District Centre
Yaoundé
About this study
Official title: Using Indigenous Foods to Reduce Malnutrition in Children
The purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.
Read the detailed description
Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.
- Conditions
- Wasting, Moderate Acute Malnutrition
- Being tested
- A daily ration of 40 kcal/kg of body weight during 56 days
- Medical subject headings
- Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A daily ration of 40 kcal/kg of body weight during 56 daysDietary supplement
On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.
| Study group | Role | What they receive |
|---|---|---|
| Ready to Use Suplementary Food (RUSF) | Experimental | A daily ration of 40 kcal/kg of body weight during 56 days Receives: Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days |
| Corn Soya Blend (CSB+) | Active comparator | A daily ration of 40 kcal/kg of body weight during 56 days Receives: Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery rate of the children receiving CSB+ or RUSF
Children with Weight-for-Height Z-score > -2
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionJul 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WastingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Food and Nutrition Research, Yaounde
- Sponsor type
- Other government
- Collaborators
- International Atomic Energy Agency
- Responsible party
- Principal investigator, Medoua Nama Gabriel, Centre for Food and Nutrition Research, Yaounde
- Investigators
- Gabriel Medoua Nama, Ph.D., Principal investigator, Centre for Food and Nutrition Research, IMPM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01898871
- Sponsor's protocol ID
- CMR6010
- Status last verified
- Jul 2013
- First submitted
- 10 Jul 2013
- Last updated
- 12 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Indigenous Foods to Reduce Malnutrition in Children
- ClinicalTrials.gov ID
- NCT01898871
- Acronym / sponsor ID
- CMR6010
- Conditions
- Wasting, Moderate Acute Malnutrition
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Centre for Food and Nutrition Research, YaoundeOther government
- Collaborators
- International Atomic Energy Agency
- Study start
- Feb 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Jul 2013 (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 purpose of this study is to determine whether an improved corn-soya blend (CSB+) and a new formulated ready-to-use supplementary food (RUSF) are effective in the treatment of moderate acute malnutrition in children.
Detailed description
Assuming the availability of some food in the household, the caregivers were instructed on how best to use the food they have and the quantity of supplementary food distributed was calculated to provide about 50% of child energy requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ready to Use Suplementary Food (RUSF) | Experimental | Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 daysA daily ration of 40 kcal/kg of body weight during 56 days |
| Corn Soya Blend (CSB+) | Active comparator | Dietary Supplement: A daily ration of 40 kcal/kg of body weight during 56 daysA daily ration of 40 kcal/kg of body weight during 56 days |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 6-59 month
- Weight-for-height between -3 and -2 z-scores without edema
- Good appetite
- Stable clinical conditions
Key exclusion criteria (4 listed)
- Weight-for-Height Z-score < -3
- Presence of bilateral pitting edema
- Unstable clinical conditions
- Not showing appetite
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 |
|---|---|---|
| A daily ration of 40 kcal/kg of body weight during 56 daysOn enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg. | Dietary supplement | Corn Soya Blend (CSB+), Ready to Use Suplementary Food (RUSF) |
Primary outcome
Recovery rate of the children receiving CSB+ or RUSF
Time frame: 56 days
Children with Weight-for-Height Z-score > -2
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 12 Jul 2013.
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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.
Gabriel Medoua Nama, Ph.D. principal investigator
Centre for Food and Nutrition Research, IMPM
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A daily ration of 40 kcal/kg of body weight during 56 days in people with Wasting and Moderate Acute Malnutrition, run by Centre for Food and Nutrition Research, Yaounde at 2 sites in Cameroon.
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 4 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 12 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Cameroon. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Recovery rate of the children receiving CSB+ or RUSF (time frame: 56 days). 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 12 Jul 2013.