Nutritional Intervention For The Treatment Of Uncomplicated SAM
SAM
1 other identifier
interventional
200
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2020
CompletedFirst Submitted
Initial submission to the registry
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedFirst Posted
Study publicly available on registry
May 25, 2022
CompletedMay 25, 2022
April 1, 2022
9 months
December 13, 2021
May 19, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Weight gain in kilograms
60 Days
Study Arms (2)
control group
PLACEBO COMPARATORstarch (placebo) 4 grams per day for 60 days
Interventional group
EXPERIMENTALPrebiotics (GOS) Galactooligosaccharides 4 gram per day for 60 days
Interventions
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 therapeutic food (RUTF) as per WHO standard and (Starch Placebo) soluble in water and mix in food on daily basis for 60 Days
Eligibility Criteria
You may qualify if:
- Uncomplicated Severely Acute Malnourished Children
You may not qualify if:
- Severely Acute Malnourished children with complication
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanaullah Iqballead
- University of the Punjabcollaborator
Study Sites (1)
DG Khan
Dera Ghazi Khan, Punjab Province, 32200, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
javeria saleem, pub. health
University of Punjab
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 13, 2021
First Posted
May 25, 2022
Study Start
January 4, 2020
Primary Completion
September 15, 2020
Study Completion
March 15, 2022
Last Updated
May 25, 2022
Record last verified: 2022-04