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

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.

Study Overview

• Status: Completed
• Conditions: Malnutrition in Children
• Intervention / Treatment: Dietary supplement: Vitamin D; Dietary supplement: Ready to Use Therapeutic Food (RUTF)

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 Type: Interventional
• Enrollment (Actual): 185
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 4 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RUTF with 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.	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.; Dietary supplement: 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.
Placebo Comparator: RUTF with Placebo; Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight gain in children	More than 15% weight gain from enrollment date	2 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Developmental Milestones of children	Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2)	2 Months

Collaborators and Investigators

• Sponsor: University of the Punjab
• Investigators: Study Director: Muhammad Z Zakar, PhD, University of the Punjab

Publications and helpful links

General Publications

• Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Peña-Rosas JP, Mehta S. Effects of oral vitamin D supplementation on linear growth and other health outcomes among children under five years of age. Cochrane Database Syst Rev. 2020 Dec 8;12:CD012875. doi: 10.1002/14651858.CD012875.pub2.
• Saleem J, Zakar R, Zakar MZ, Belay M, Rowe M, Timms PM, Scragg R, Martineau AR. High-dose vitamin D3 in the treatment of severe acute malnutrition: a multicenter double-blind randomized controlled trial. Am J Clin Nutr. 2018 May 1;107(5):725-733. doi: 10.1093/ajcn/nqy027.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 16, 2016
• First Submitted That Met QC Criteria: May 25, 2017
• First Posted (Actual): May 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 31, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Malnutrition; Child Nutrition Disorders; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: UPunjab

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No