Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
Primary Purpose
Malnutrition in Children
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Vitamin D
Ready to Use Therapeutic Food (RUTF)
Sponsored by
About this trial
This is an interventional supportive care trial for Malnutrition in Children
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RUTF with Vitamin D
RUTF with Placebo
Arm Description
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.
Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.
Outcomes
Primary Outcome Measures
Weight gain in children
More than 15% weight gain from enrollment date
Secondary Outcome Measures
Developmental Milestones of children
Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2)
Full Information
NCT ID
NCT03170479
First Posted
October 16, 2016
Last Updated
May 25, 2017
Sponsor
University of the Punjab
1. Study Identification
Unique Protocol Identification Number
NCT03170479
Brief Title
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
Official Title
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of the Punjab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU).
Study design: Randomized Controlled Trial.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition in Children
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RUTF with Vitamin D
Arm Type
Experimental
Arm Description
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.
Arm Title
RUTF with Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ready to Use Therapeutic Food (RUTF)
Intervention Description
RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.
Primary Outcome Measure Information:
Title
Weight gain in children
Description
More than 15% weight gain from enrollment date
Time Frame
2 Months
Secondary Outcome Measure Information:
Title
Developmental Milestones of children
Description
Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2)
Time Frame
2 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muhammad Z Zakar, PhD
Organizational Affiliation
University of the Punjab
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
33305842
Citation
Huey SL, Acharya N, Silver A, Sheni R, Yu EA, Pena-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(12):CD012875. doi: 10.1002/14651858.CD012875.pub2.
Results Reference
derived
PubMed Identifier
29722846
Citation
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.
Results Reference
derived
Learn more about this trial
Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan
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