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Nutritional Intervention For The Treatment Of Uncomplicated SAM (SAM)

Primary Purpose

Child Nutrition Disorders

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination

Ready to use theraputic food (RUTF) and Starch (placebo)

About this trial

This is an interventional treatment trial for Child Nutrition Disorders

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

Severely Acute Malnourished children with complication

Sites / Locations

DG Khan

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

control group

Interventional group

Arm Description

starch (placebo) 4 grams per day for 60 days

Prebiotics (GOS) Galactooligosaccharides 4 gram per day for 60 days

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Weight gain in kilograms

weight will be measured on electronic scale on a flat level surface

Full Information

NCT ID

NCT05390437

First Posted

December 13, 2021

Last Updated

May 19, 2022

Sponsor

Sanaullah Iqbal

Collaborators

University of the Punjab

1. Study Identification

Unique Protocol Identification Number

NCT05390437

Brief Title

Nutritional Intervention For The Treatment Of Uncomplicated SAM

Acronym

SAM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

January 4, 2020 (Actual)

Primary Completion Date

September 15, 2020 (Actual)

Study Completion Date

March 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sanaullah Iqbal

Collaborators

University of the Punjab

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Child Nutrition Disorders

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare Provider

Allocation

Randomized

Enrollment

200 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control group

Arm Type

Placebo Comparator

Arm Description

starch (placebo) 4 grams per day for 60 days

Arm Title

Interventional group

Arm Type

Experimental

Arm Description

Prebiotics (GOS) Galactooligosaccharides 4 gram per day for 60 days

Intervention Type

Dietary Supplement

Intervention Name(s)

Nutritional intervention with Ready to use theraputic food (RUTF) and prebiotic GOS (galacto oligosaccharides) in combination

Intervention Description

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

Intervention Type

Dietary Supplement

Intervention Name(s)

Ready to use theraputic food (RUTF) and Starch (placebo)

Intervention Description

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

Primary Outcome Measure Information:

Title

Nutritional cure

Description

Time Frame

60 Days

Secondary Outcome Measure Information:

Title

Weight gain in kilograms

Description

weight will be measured on electronic scale on a flat level surface

Time Frame

60 Days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

59 Months

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

javeria saleem, pub. health

Organizational Affiliation

University of Punjab

Official's Role

Principal Investigator

Facility Information:

Facility Name

DG Khan

City

Dera Ghazi Khan

State/Province

Punjab

ZIP/Postal Code

32200

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

Nutritional Intervention For The Treatment Of Uncomplicated SAM

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