Nutritional Intervention For The Treatment Of Uncomplicated SAM

Child Nutrition Disorders Clinical Trial

— SAM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05390437
• Other study ID #: Uncomplicated SAM
• Status: Completed
• Phase: N/A
• Start date: January 4, 2020
• Est. completion date: March 15, 2022

Study information

• Verified date: April 2022
• Source: University of Veterinary and Animal Sciences, Lahore - Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 15, 2022
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria:

• Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

• Severely Acute Malnourished children with complication

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Nutrition Disorders

Intervention

Dietary Supplement:
• Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination
4gm of prebiotic GOS ( Galactooligosaccharides) and Ready to use theraputic food (RUTF) as per WHO standard on daily basis for 60 Days
• Ready to use theraputic food (RUTF) and Starch (placebo)
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

Locations

Country	Name	City	State
Pakistan	DG Khan	Dera Ghazi Khan	Punjab

Sponsors (2)

Lead Sponsor	Collaborator
Sanaullah Iqbal	University of the Punjab

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight gain in kilograms	weight will be measured on electronic scale on a flat level surface	60 Days