NCT03170479

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
185

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2016

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.4 years

First QC Date

October 16, 2016

Last Update Submit

May 25, 2017

Conditions

Malnutrition in Children

Outcome Measures

Primary Outcomes (1)

  • Weight gain in children

    More than 15% weight gain from enrollment date

    2 Months

Secondary Outcomes (1)

  • Developmental Milestones of children

    2 Months

Study Arms (2)

RUTF with Vitamin D

EXPERIMENTAL

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 DDietary Supplement: Ready to Use Therapeutic Food (RUTF)

RUTF with Placebo

PLACEBO COMPARATOR

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)

Interventions

Vitamin DDIETARY_SUPPLEMENT

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.

RUTF with Vitamin D
Ready to Use Therapeutic Food (RUTF)DIETARY_SUPPLEMENT

RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.

RUTF with PlaceboRUTF with Vitamin D

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 33305842DERIVED

  • 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.

    PMID: 29722846DERIVED

MeSH Terms

Conditions

Child Nutrition Disorders

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Muhammad Z Zakar, PhD

    University of the Punjab

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 16, 2016

First Posted

May 31, 2017

Study Start

June 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will share