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Clinical Trials/NCT03170479
NCT03170479
Completed
Phase 2

Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan

University of the Punjab0 sites185 target enrollmentJune 2015

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Malnutrition in Children
Sponsor
University of the Punjab
Enrollment
185
Primary Endpoint
Weight gain in children
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

i. To examine the impact of malnutrition on development quotient of children

ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age.

iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.

Detailed Description

1. Research Instrument: For Development quotient Denver 2 screening form and tools will be used. Follow up of patients for three months and for recording of their weight Community management of acute malnutrition forms will be used. Denver screening tool will be used for child development quotient covering all areas of development, fine motor, gross motor, language and personal social contact. 2. Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU). 3. Study design: Randomized Controlled Trial. 4. Data Collection: Lady Health Visitors (LHWs) will screen the children aged 6 months to 59 months in their community and will refer the severely malnourished children to Outpatient Therapeutic Programs (OTPs).Two groups of malnourished children will be made one study and one control group; one group will be treated with RUTF and extra virgin olive oil as placebo. Other will with RUTF and two mega doses of Vitamin D randomly, first after 15 days of enrollment and second after 15 days of first dose.

Registry
clinicaltrials.gov
Start Date
June 2015
End Date
May 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Javeria Saleem

Principal Investigator

University of the Punjab

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Weight gain in children

Time Frame: 2 Months

More than 15% weight gain from enrollment date

Secondary Outcomes

  • Developmental Milestones of children(2 Months)

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