Nutritional Intervention For The Treatment Of Uncomplicated SAM

Study Overview
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Brief Summary
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nutritional intervention with ready to use therapeutic food (plumpy nut. by Unicef) and Prebiotics supplimentation ( Galactooligosaccarides). will be given to uncomplicated severe acute malnourished children of 06 months to 59 months of age in southern Punjab Pakistan.one group will be given Ready to use therapeutic food and placebo the other group will be given Prebiotics supplementation (Galacto oligosaccharides) with RUTF ( Ready to use therapeutic Foods).for 60 days primary out will be Mid Upper Arm Circumference >11.5 centimetre

Detailed Description
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it will be a double blind Randomised Controlled trial in Out Therapeutic Program centres of Teaching Hospital of Dera Ghazi Khan Pakistan children age of 06 months to 59 months of age from the community will be screened out at health centres . Uncomplicated SAM children will be enrolled for study Before intervention there blood sample and stool sample will be sent to the labs for complete blood examination and complete stool examination. controlled groups will be given Ready To use Therapeutic Food and Placebo (starch) 4 grams per day for 60 days Intervention group will be given Ready to use Therapeutic Food and Prebiotic ( Galactoligosaccharides 4 gram per day for 60 days

Official Title
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Nutritional Intervention For The Treatment Of Uncomplicated Severe Acute Malnutrition in South Punjab Pakistan

Conditions
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Child Nutrition Disorders

Intervention / Treatment
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* Dietary Supplement: Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination
* Dietary Supplement: Ready to use theraputic food (RUTF) and Starch (placebo)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Uncomplicated Severely Acute Malnourished Children Exclusion Criteria: Severely Acute Malnourished children with complication

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group<br>starch (placebo) 4 grams per day for 60 days | Dietary Supplement: Ready to use theraputic food (RUTF) and Starch (placebo)<br>* Ready to use therapeutic food (RUTF) as per WHO standard and (Starch Placebo) soluble in water and mix in food on daily basis for 60 Days<br>|
| Experimental: Interventional group<br>Prebiotics (GOS) Galactooligosaccharides 4 gram per day for 60 days | Dietary Supplement: Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination<br>* 4gm of prebiotic GOS ( Galactooligosaccharides) and Ready to use theraputic food (RUTF) as per WHO standard on daily basis for 60 Days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional cure | Mid Upper Arm Circumference of left arm is measured at the mid point between the tips of shoulder and elbow.It is measured by MUAC tape . More than 11.5 centimetre according to WHO criteria will be primary outcome | 60 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain in kilograms | weight will be measured on electronic scale on a flat level surface | 60 Days |