Nutritional Intervention For The Treatment Of Uncomplicated SAM

Sponsor

Sanaullah Iqbal (Other)

Overall Status

Completed

CT.gov ID

NCT05390437

Collaborator

University of the Punjab (Other)

200

Enrollment

Location

Arms

26.3

Actual Duration (Months)

7.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Child Nutrition Disorders	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)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 4, 2020

Actual Primary Completion Date :

Sep 15, 2020

Actual Study Completion Date :

Mar 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control group starch (placebo) 4 grams per day for 60 days	Dietary Supplement: 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
Experimental: Interventional group 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 4gm of prebiotic GOS ( Galactooligosaccharides) and Ready to use theraputic food (RUTF) as per WHO standard on daily basis for 60 Days

Arm

Intervention/Treatment

Placebo Comparator: control group

starch (placebo) 4 grams per day for 60 days

Dietary Supplement: 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

Experimental: Interventional group

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

4gm of prebiotic GOS ( Galactooligosaccharides) and Ready to use theraputic food (RUTF) as per WHO standard on daily basis for 60 Days

Outcome Measures

Primary Outcome Measures

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

Weight gain in kilograms [60 Days]
weight will be measured on electronic scale on a flat level surface

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Months to 59 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

Severely Acute Malnourished children with complication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	DG Khan	Dera Ghazi Khan	Punjab	Pakistan	32200

Sponsors and Collaborators

Sanaullah Iqbal
University of the Punjab

Investigators

Principal Investigator: javeria saleem, pub. health, University of Punjab

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sanaullah Iqbal, Associate Professor, University of Veterinary and Animal Sciences, Lahore - Pakistan

ClinicalTrials.gov Identifier:

NCT05390437

Other Study ID Numbers:

Uncomplicated SAM

First Posted:

May 25, 2022

Last Update Posted:

May 25, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nutrition Disorders

Child Nutrition Disorders

Study Results

No Results Posted as of May 25, 2022