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

Malnutrition in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03170479
• Other study ID #: UPunjab
• Status: Completed
• Phase: Phase 2
• First received: October 16, 2016
• Last updated: May 25, 2017
• Start date: June 2015
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: University of the Punjab
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 59 Months

Eligibility

Inclusion Criteria

• All the selected children of Severe uncomplicated acute malnutrition of concerned age group whose parents or guardians have give written consent for the study

• Mid Upper Arm Circumference (MUAC) less than 11.5 cm or Weight For Height (WFH) less then minus 3 standard deviation.

Exclusion Criteria

• Children above the concerned age group

• Refusal of parents for taking part in the study.

• Child having Severe Acute Malnutrition (SAM) with complications have loss of appetite, lower respiratory tract infection indicated by chest in drawing, severe vomiting.

• Temperature greater then 39°C or hypothermia less then 35°C, very pale, oedema, unconsciousness.

Related Conditions & MeSH terms

• Child Nutrition Disorders
• Malnutrition
• Malnutrition in Children

Intervention

Dietary Supplement:
• Vitamin D
Two doses of Vitamin D supplementation in ampoules form (ED3) were procured. Ampoule contains Cholecalciferol in 200,000 IU both for oral and intra muscular use.
• Ready to Use Therapeutic Food (RUTF)
RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of the Punjab

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight gain in children	More than 15% weight gain from enrollment date	2 Months
Secondary	Developmental Milestones of children	Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2)	2 Months