Nutritional Intervention For The Treatment Of Uncomplicated SAM (SAM)

May 19, 2022 updated by: Sanaullah Iqbal

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Dera Ghazi Khan, Punjab, Pakistan, 32200
        • DG Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria:

  • Severely Acute Malnourished children with complication

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutritional cure
Time Frame: 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
60 Days

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanaullah Iqbal

Collaborators

University of the Punjab

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2020

Primary Completion (Actual)

September 15, 2020

Study Completion (Actual)

March 15, 2022

Study Registration Dates

First Submitted

December 13, 2021

First Submitted That Met QC Criteria

May 19, 2022

First Posted (Actual)

May 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 25, 2022

Last Update Submitted That Met QC Criteria

May 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uncomplicated SAM

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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