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

Phase 2

Completed

• Conditions: Malnutrition in Children
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

• Registration Number: NCT03170479
• Lead Sponsor: University of the Punjab

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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-10-16
• Primary Completion: 2016-11
• Status Verified: 2017-05
• Study Completion: 2017-05
• Study First Submitted QC: 2017-05-25
• Last Update Submitted: 2017-05-25
• Study First Posted: 2017-05-31
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 185

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RUTF with Vitamin D	Vitamin D	Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose.
RUTF with Vitamin D	Ready to Use Therapeutic Food (RUTF)	Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose.
RUTF with Placebo	Ready to Use Therapeutic Food (RUTF)	Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.

Primary Outcome Measures

Name	Time	Method
Weight gain in children	2 Months	More than 15% weight gain from enrollment date

Secondary Outcome Measures

Name	Time	Method
Developmental Milestones of children	2 Months	Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2)