Nutritional Intervention For The Treatment Of Uncomplicated SAM

NCT ID: NCT05390437

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-04

Study Completion Date

2022-03-15

Brief Summary

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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

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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

Conditions

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Child Nutrition Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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control group

starch (placebo) 4 grams per day for 60 days

Group Type PLACEBO_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventional group

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

Group Type EXPERIMENTAL

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

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Uncomplicated Severely Acute Malnourished Children

Exclusion Criteria

* Severely Acute Malnourished children with complication
Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of the Punjab

OTHER

Sponsor Role collaborator

Sanaullah Iqbal

OTHER

Sponsor Role lead

Responsible Party

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Sanaullah Iqbal

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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javeria saleem, pub. health

Role: PRINCIPAL_INVESTIGATOR

University of Punjab

Locations

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DG Khan

Dera Ghazi Khan, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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Uncomplicated SAM

Identifier Type: -

Identifier Source: org_study_id

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