Severe and Moderate MalnutritionNCT00941434
Community Based Management of Malnutrition
A study testing RUTF in people with Severe and Moderate Malnutrition, run by Aga Khan University at 1 site in Pakistan.
Trial summary
Malnutrition is the leading cause of death in children in developing countries, especially Pakistan. According to World Health Organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Severe and Moderate Malnutrition
- What is being tested?
- RUTF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2009to Sep 2010
- 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 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Born and eligible for inclusion within the study period.
- Presence of moderate to severe malnutrition.
- Ability of the parents or guardians to provide informed consent
Who cannot join
- Presence of chronic debilitating illness.
- Residence outside of study areas.
- Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns
Malnutrition is the leading cause of death in children in developing countries, especially Pakistan. According to World Health Organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition.
Community-based therapeutic care attempts to maximize population-level impact through improved coverage, access, and cost-effectiveness of treatment. Such community-based nutrition packages can provide effective care to the majority of acutely malnourished children as outpatients, using techniques of community mobilization to engage the affected population and maximize coverage and compliance. Children with SAM without medical complications are treated in an outpatient therapeutic program with ready-to-use therapeutic food and routine medications.
The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized the treatment of moderate and severe malnutrition. The advantage of these commodities is that they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the risk of bacterial proliferation in case of accidental contamination.
Read the detailed description
Aim:
To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement (Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when administered at community level
Primary objectives:
- To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified supplementary food (RUTF) in the treatment of moderate malnutrition in children less than three years of age in community settings.
- To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of severe malnutrition in children less than three years of age in community settings.
Methodology:
Study Design: Community based, step wedge randomized trial
Sample size estimation:
Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040 (Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520 (Assuming 50% of Under 5 Population)
Sample Size for Moderate Malnutrition:
It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520: 904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or drop outs)
Sample Size For Severe Malnutrition:
It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of 4520: 360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or drop outs)
- Conditions
- Severe and Moderate Malnutrition
- Being tested
- RUTF
- Keywords
- RUTF, SAM, Nutributter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RUTFDietary supplement
Children with severe malnutrition will be treated with a daily dose of RUTF till their weight for age z scores no longer fall in severe malnutrition group
| Study group | Role | What they receive |
|---|---|---|
| RUTF | Experimental | Children with Severe malnutrition will be treated with Ready to use therapeutic food (RUTF) till their weight for age z scores are no longer in severe malnutrition group Receives: Dietary Supplement: RUTF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved Growth Parameters Weight for Age Z Scores.
Measured: 1 year
Secondary outcomes (1)
Reduction in Malnutrition related morbidity and mortality patterns in early childhood
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startJul 2009
- Primary completionJun 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe and Moderate MalnutritionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- John Snow, Inc., Pakistan Ministry of Health
- Investigators
- Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD, Principal investigator, Women and Child Health Division, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941434
- Sponsor's protocol ID
- 1227-Ped/ERC-09
- Status last verified
- Jul 2009
- First submitted
- 16 Jul 2009
- Last updated
- 8 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns
- ClinicalTrials.gov ID
- NCT00941434
- Acronym / sponsor ID
- 1227-Ped/ERC-09
- Conditions
- Severe and Moderate Malnutrition
- Keywords
- RUTF, SAM, Nutributter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- John Snow, Inc., Pakistan Ministry of Health
- Study start
- Jul 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 17 Jul 2009 (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.
Malnutrition is the leading cause of death in children in developing countries, especially Pakistan. According to World Health Organization about 60% of all deaths, occurring among children aged less than five years in developing countries, could be attributed to malnutrition.
Community-based therapeutic care attempts to maximize population-level impact through improved coverage, access, and cost-effectiveness of treatment. Such community-based nutrition packages can provide effective care to the majority of acutely malnourished children as outpatients, using techniques of community mobilization to engage the affected population and maximize coverage and compliance. Children with SAM without medical complications are treated in an outpatient therapeutic program with ready-to-use therapeutic food and routine medications.
The Ready-to-use Therapeutic Food (RUTF) and Fortified Supplementary food has revolutionized the treatment of moderate and severe malnutrition. The advantage of these commodities is that they are ready-to-use paste which does not need to be mixed with water, thereby avoiding the risk of bacterial proliferation in case of accidental contamination.
Detailed description
Aim:
To evaluate the effectiveness of Ready to Use Therapeutic food and food supplement (Nutributter) in the treatment of Moderate and Severe malnutrition in rural Pakistan when administered at community level
Primary objectives:
- To assess the acceptability, feasibility and effectiveness of Nutributter and Fortified supplementary food (RUTF) in the treatment of moderate malnutrition in children less than three years of age in community settings.
- To assess the acceptability, feasibility and effectiveness of RUTF in the treatment of severe malnutrition in children less than three years of age in community settings.
Methodology:
Study Design: Community based, step wedge randomized trial
Sample size estimation:
Total Population of the study area: 60268. Estimated under 5 years of age Population: 9040 (Assuming 15% of Total population. Estimated Population between 6 months to 3 years: 4520 (Assuming 50% of Under 5 Population)
Sample Size for Moderate Malnutrition:
It is estimated that the Prevalence of Moderately Malnourished: 20% Therefore 20% of 4520: 904. We anticipate recruiting 1000 cases (96 about 10% extra for any loss to follow-ups or drop outs)
Sample Size For Severe Malnutrition:
It is estimated that the prevalence of Severe Acute Malnutrition is 8%. Therefore 8% of 4520: 360. We anticipate recruiting 400 cases (40 about 10% extra for any loss to follow-ups or drop outs)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RUTF | Experimental | Dietary Supplement: RUTFChildren with Severe malnutrition will be treated with Ready to use therapeutic food (RUTF) till their weight for age z scores are no longer in severe malnutrition group |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Born and eligible for inclusion within the study period.
- Presence of moderate to severe malnutrition.
- Ability of the parents or guardians to provide informed consent
Key exclusion criteria (3 listed)
- Presence of chronic debilitating illness.
- Residence outside of study areas.
- Inability or refusal of the parents or guardians to give informed consent, or refusal of assessment.
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 |
|---|---|---|
| RUTFChildren with severe malnutrition will be treated with a daily dose of RUTF till their weight for age z scores no longer fall in severe malnutrition group | Dietary supplement | RUTF |
Primary outcome
Improved Growth Parameters Weight for Age Z Scores.
Time frame: 1 year
1 secondary outcome
Reduction in Malnutrition related morbidity and mortality patterns in early childhood
Time frame: 1 year
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 8 Jul 2011.
Related trials for Severe and Moderate Malnutrition
Active, not recruiting
Regular Growth Monitoring (RGM) of Young Children in Guinea-Bissau
Severe Acute Malnutrition, Moderate Acute Malnutrition (MAM)
Not yet recruiting
Reduced Dosage and/or Visitation Protocol for the Treatment of Acute Malnutrition in Kenya
Acute Malnutrition in Childhood, Acute Malnutrition, Severe
Not yet recruiting
Management of Undernutrition on Discharge From Hospital by Dieticians and Physical Activity Teachers at Home
Malnutrition Severe, Malnutrition; Moderate
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.
Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD principal investigator
Women and Child Health Division, Aga Khan 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 RUTF in people with Severe and Moderate Malnutrition, run by Aga Khan University at 1 site in Pakistan.
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: finished, as of the sponsor's last update on 8 Jul 2011. 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 Pakistan. 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?
Improved Growth Parameters Weight for Age Z Scores. (time frame: 1 year). 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 8 Jul 2011.