Nutritional Intervention For The Treatment Of Uncomplicated SAM

Not Applicable

Completed

• Conditions: Child Nutrition Disorders
• Interventions: Dietary Supplement: Ready to use theraputic food (RUTF) and Starch (placebo); Dietary Supplement: Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination

• Registration Number: NCT05390437
• Lead Sponsor: Sanaullah Iqbal

Brief Summary

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

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

Study Timeline

• Study Start: 2020-01-04
• Primary Completion: 2020-09-15
• Study First Submitted: 2021-12-13
• Study Completion: 2022-03-15
• Status Verified: 2022-04
• Study First Submitted QC: 2022-05-19
• Last Update Submitted: 2022-05-19
• Study First Posted: 2022-05-25
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria

• Severely Acute Malnourished children with complication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	Ready to use theraputic food (RUTF) and Starch (placebo)	starch (placebo) 4 grams per day for 60 days
Interventional group	Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination	Prebiotics (GOS) Galactooligosaccharides 4 gram per day for 60 days

Primary Outcome Measures

Name	Time	Method
Nutritional cure	60 Days	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

Secondary Outcome Measures

Name	Time	Method
Weight gain in kilograms	60 Days	weight will be measured on electronic scale on a flat level surface

Trial Locations

Locations (1)

DG Khan; 🇵🇰 Dera Ghazi Khan, Punjab, Pakistan