- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00941434
Community Based Management of Malnutrition
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
-
Dadu, Sindh, Pakistan
- AKU Project Office
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: RUTF
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Improved Growth Parameters Weight for Age Z Scores.
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in Malnutrition related morbidity and mortality patterns in early childhood
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD, Women and Child Health Division, Aga Khan University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1227-Ped/ERC-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Severe and Moderate Malnutrition
-
Action Against Hunger USAUniversity of Washington; Ethiopian Public Health InstituteNot yet recruitingModerate Acute Malnutrition | Severe Acute Malnutrition
-
Microbiome Health Research InstituteUniversity of Cape TownTerminatedModerate Acute Malnutrition | Severe Acute MalnutritionSouth Africa
-
International Centre for Diarrhoeal Disease Research...CompletedModerate and Severe UndernutritionBangladesh
-
Alliance for International Medical ActionBien Être de La femme et de L'Enfant au NigerCompletedMalnutrition | Kwashiorkor | Marasmus | Malnutrition; Degree, ModerateNiger
-
Washington University School of MedicineThrasher Research Fund; Project Peanut Butter; Ministry of Health and Sanitation...RecruitingEnvironmental Enteric Dysfunction | Moderate Acute Malnutrition | Stunting | Severe Acute MalnutritionSierra Leone
-
Alliance for International Medical ActionMinistry of Public Health, Democratic Republic of the Congo; University of... and other collaboratorsCompletedModerate Acute Malnutrition | Severe Acute Malnutrition | Randomized Clinical Trial | Child Malnutrition | Africa | Acute Malnutrition | Congo, The Democratic Republic of theCongo, The Democratic Republic of the
-
Beer, Kenneth R., M.D., PAMedicis Pharmaceutical CorporationCompletedMild to Moderate Temporal Atrophy | Moderate to Severe Glabellar Rhytids | Moderate to Severe Periorbital RhytidsUnited States
-
Daewoong Pharmaceutical Co. LTD.CompletedModerate-severe Glabellar Lines
-
Aqpha Medical B.V.Not yet recruitingModerate to Severe Nasolabial Fold
-
Daewoong Pharmaceutical Co. LTD.Completed
Clinical Trials on RUTF
-
International Centre for Diarrhoeal Disease Research...UNICEF; NutrisetCompletedSevere Acute Malnutrition in ChildhoodBangladesh
-
Washington University School of MedicineProject Peanut Butter, Sierra Leone; Ministry of Health and Sanitation, Government...CompletedMalnutrition, ChildSierra Leone
-
EpicentreEpicentre, Niger; National Nutrition Direction, Niger; Ministry of Public Health... and other collaboratorsCompletedMalnutrition, ChildNiger
-
Washington University School of MedicineThe Children's Investment Fund FoundationCompleted
-
The Hospital for Sick ChildrenMinistry of Health, Malawi; Nutriset; Schlumberger Foundation; Friends of Sick...RecruitingSevere Acute Malnutrition | Severe WastingMalawi
-
Cheikh Anta Diop University, SenegalUNICEFCompletedMalnutrition | HIV-infection/AidsSenegal
-
Aga Khan UniversityInternational Atomic Energy AgencyCompletedMalnutrition | ChildrenPakistan
-
University of OxfordKEMRI-Wellcome Trust Collaborative Research ProgramCompletedSevere Acute MalnutritionKenya
-
Medecins Sans Frontieres, NetherlandsCompletedWeight Loss | Malaria | Weight Gain | ConvalescenceCongo
-
Washington University School of MedicineCornell University; Kamuzu University of Health Sciences; University of Texas...CompletedSevere Acute MalnutritionMalawi