search
Back to results

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
University of the Punjab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Malnutrition in Children

Eligibility Criteria

6 Months - 59 Months (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 16, 2016
    Last Updated
    May 25, 2017
    Sponsor
    University of the Punjab
    search

    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

    We'll reach out to this number within 24 hrs