- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04045249
Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition
August 2, 2019 updated by: Dr. Zahra Khan, Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
Comparison Between Different Feeding Protocols and Existing Protocol for the Treatment of Acute Malnutrition (A Cluster Randomized Controlled Clinical Trial)
Though malnutrition is prevalent worldwide but its situation is alarming in low- and middle-income countries.
Pakistan has also been facing an alarming situation of prevailing severe malnutrition.
Malnutrition in its any form costs a huge intolerable burden not only on national health care system, but also on social and economic fabric of the nation.
The current management of severe malnutrition is based on World Health Organization (WHO) guidelines and protocols which has been evolved from expert opinions and observational studies.
The principles of these protocols have emerged from emergency settings and converting these protocols for developing countries where severe malnutrition, a routine burden is a critical challenge.
In the absence of standard protocols for the treatment of uncomplicated severe malnutrition in non-emergency settings it is important to test and optimize different approaches to treat severely acute malnutrition (SAM).
It is hypothesized that by optimizing, adapting and implementing time oriented and resource intensive approaches, a huge burden of high cost of RUTF may be reduced.
While RUTF may be utilized to treat SAM children in emergency settings, it is not a substitute of local household foods.
Therefore, a pilot study has been conducted to compare the various treatment protocols for malnourished children.
We specifically hypothesized that a reduced dose of RUTF for reduced duration, combined with age-appropriate food intake from locally available resources can treat uncomplicated SAM children cost effectively as compared to standard national Community Management of Acute Malnutrition (CMAM) protocol currently implemented in Punjab, Pakistan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Malnutrition signifies to inadequacies, immoderations or imbalances in an individual's consumption of nutrients or energy.
The word malnutrition covers both under and over-nutrition.
Undernutrition manifest in two different ways acute and chronic malnutrition.
The acute malnutrition includes wasting while chronic malnutrition includes stunting.
The situation of malnutrition has been perplexed in Pakistan in recent years and according to National Nutrition Survey (2018) rates of wasting are alarmingly high.
Also, Pakistan ranks at 2nd position for infant and child mortality.
The standard treatment of uncomplicated SAM in Pakistan often utilizes prolonged use of therapeutic food (RUTF), and after discharge results in high rates of relapse(official data from department of Health doesn't support this statement, according to them there is low rate of relapse).
The present pilot study was conducted with the objective to find cost effective treatment protocols for treatment of uncomplicated SAM children.
The study was conducted at The Children's Hospital and Institute of Child Health, Lahore in Out Patient Therapeutic Program (OTP) of Preventive Pediatrics Department.
The children diagnosed with SAM aged 6-59 months without any specific gender preference were recruited.
Weight, height and MUAC were measured at the time of enrolment in the study and Weight for Height (WHZ), Weight for Age (WAZ), Height for Age (HAZ) standard deviation (SD) Z scores and weight velocity was calculated for baseline.
For current pilot study SAM children were grouped into 3 clusters.
First, 30 children were grouped in 1st cluster, next 30 in 2nd cluster and further next 30 in 3rd cluster.
Children in 1st cluster were treated as per standard CMAM protocols.
Children in this cluster were provided RUTF as per admission weight of child until they attain 11.5cm MUAC or >-3SD WHZ.
The children in the 2nd group (1st intervention group) were initially provided RUTF until they attain MUAC 11cm.
After this, children were provided 50% of their required daily calories intake by RUTF and 50% of the calories were provided by the home-based food.
The children in the 3rd group (2nd intervention group) were initially provided RUTF until they attain MUAC 11 cm.
After this, children were provided their 100% caloric requirement from home-based food along with micronutrients sachets (MMS).
The discharge criteria for control group was according to the existing CMAM guidelines that is MUAC > 11.5 cm.
The discharge criteria for 2nd & 3rd group was MUAC > 12.5 cm and WHZ > -2SD score.
Follow-up home visits of all children were done according to a predefined protocol.
During follow-up the control and intervention groups underwent weekly anthropometric measurements.
Follow up of the study participants of each group was continued for one month.
Growth rate, recovery rate, mortality rate, relapse frequency and duration of recovery were calculated for each group.
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Punjab
-
Lahore, Punjab, Pakistan, 54000
- The Children's Hospital & The Institute of Child Health
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 4 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children 6-59 months with MUAC <11.5cm and Weight for Height Z score < -3SD
- Having good appetite, alert and clinically well
Exclusion Criteria:
- WHZ score - 4 SD
- MUAC < 8 cm
- Secondary malnutrition diagnosed by a gastroenterologist and dietitian
- Family History
- Birth Anomolies
- Any hidden/ asymptomatic health conditions
- Any patient coming from out of city (Lahore)
- Anorexia
- High fever (>104 F)
- Severe pallor
- Severe dehydration
- Lower respiratory tract infection
- Bipedal edema
- Visible severe wasting
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1st Group
Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm
|
|
Experimental: 2nd Group (1st Intervention group)
Children were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food
|
Home based food is compare able to RUTF
|
Experimental: 3rd Group (2nd Intervention)
Children were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food
|
Home based food is compare able to RUTF
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth velocity
Time Frame: 3 months
|
Weight in Kg
|
3 months
|
Growth velocity
Time Frame: 3 months
|
Height in cm
|
3 months
|
Growth velocity
Time Frame: 3 months
|
Mid Upper Arm Circumference (MUAC) in cm
|
3 months
|
Duration of recovery from SAM
Time Frame: 3 months
|
Time required each child to reach MUAC > 11.5
|
3 months
|
Rate of relapse
Time Frame: 3 months
|
Number of children relapsed during the trial
|
3 months
|
Rate of mortality
Time Frame: 3 months
|
Number of children dying during trial
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of recovery from Moderate Acute Malnutrition in 1st group
Time Frame: 3 months
|
Proportion of children who reach MUAC > 12.5 cm
|
3 months
|
Number of children having diarrhoea and acute respiratory infection during trial
Time Frame: 3 months
|
3 months
|
|
Number of children not coming for follow up visits due to any reason
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zahra Khan, PhD, IRMNCH & Nutrition Program
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 10, 2018
Primary Completion (Actual)
April 25, 2019
Study Completion (Actual)
April 25, 2019
Study Registration Dates
First Submitted
July 29, 2019
First Submitted That Met QC Criteria
August 2, 2019
First Posted (Actual)
August 5, 2019
Study Record Updates
Last Update Posted (Actual)
August 5, 2019
Last Update Submitted That Met QC Criteria
August 2, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RUTF18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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