Clinical trial NCT00941434: Community Based Management of Malnutrition
Official title: Community Based Management of Malnutrition. A Proposal for Pakistan Initiative for Mothers and Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe and Moderate Malnutrition
Keywords: RUTF
SAM
Nutributter
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: John Snow, Inc.
name: Pakistan Ministry of Health
First posted: 2009-07-17
Enrollment: 800
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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)

Eligibility criteria: 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.

Primary outcomes:
measure: Improved Growth Parameters Weight for Age Z Scores.
timeFrame: 1 year
Secondary outcomes:
measure: Reduction in Malnutrition related morbidity and mortality patterns in early childhood
timeFrame: 1 year
Other outcomes:
Locations:
city: Dadu
country: Pakistan
facility: AKU Project Office
state: Sindh
Study officials:
affiliation: Women and Child Health Division, Aga Khan University
name: Dr. Zulfiqar A. Bhutta, MBBS, FRCP, FCPS, PhD
role: PRINCIPAL_INVESTIGATOR
References: