search
Back to results

Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition

Primary Purpose

Malnutrition, Child

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Home based food
Sponsored by
Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malnutrition, Child focused on measuring Malnutrition, RUTF, Children, Home base food

Eligibility Criteria

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

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

Sites / Locations

  • The Children's Hospital & The Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1st Group

2nd Group (1st Intervention group)

3rd Group (2nd Intervention)

Arm Description

Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm

Children were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food

Children were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food

Outcomes

Primary Outcome Measures

Growth velocity
Weight in Kg
Growth velocity
Height in cm
Growth velocity
Mid Upper Arm Circumference (MUAC) in cm
Duration of recovery from SAM
Time required each child to reach MUAC > 11.5
Rate of relapse
Number of children relapsed during the trial
Rate of mortality
Number of children dying during trial

Secondary Outcome Measures

Rate of recovery from Moderate Acute Malnutrition in 1st group
Proportion of children who reach MUAC > 12.5 cm
Number of children having diarrhoea and acute respiratory infection during trial
Number of children not coming for follow up visits due to any reason

Full Information

First Posted
July 29, 2019
Last Updated
August 2, 2019
Sponsor
Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab
search

1. Study Identification

Unique Protocol Identification Number
NCT04045249
Brief Title
Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition
Official Title
Comparison Between Different Feeding Protocols and Existing Protocol for the Treatment of Acute Malnutrition (A Cluster Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 10, 2018 (Actual)
Primary Completion Date
April 25, 2019 (Actual)
Study Completion Date
April 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Child
Keywords
Malnutrition, RUTF, Children, Home base food

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Study involved 3 arms; 1st arm was treated as per standard protocol. 2nd arm was provided half calories from RUTF and half from home based food, 3rd arm was provided home based food along with MMS
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1st Group
Arm Type
No Intervention
Arm Description
Children were treated as per standard CMAM protocols; provided RUTF until MUAC reaches 11.5 cm
Arm Title
2nd Group (1st Intervention group)
Arm Type
Experimental
Arm Description
Children were initially provided RUTF until MUAC reach 11 cm then 50 % calories were provided from RUTF and 50% calories from home based food
Arm Title
3rd Group (2nd Intervention)
Arm Type
Experimental
Arm Description
Children were initially provided RUTF until MUAC reach 11 cm then 100 % calories provided from home based food
Intervention Type
Dietary Supplement
Intervention Name(s)
Home based food
Intervention Description
Home based food is compare able to RUTF
Primary Outcome Measure Information:
Title
Growth velocity
Description
Weight in Kg
Time Frame
3 months
Title
Growth velocity
Description
Height in cm
Time Frame
3 months
Title
Growth velocity
Description
Mid Upper Arm Circumference (MUAC) in cm
Time Frame
3 months
Title
Duration of recovery from SAM
Description
Time required each child to reach MUAC > 11.5
Time Frame
3 months
Title
Rate of relapse
Description
Number of children relapsed during the trial
Time Frame
3 months
Title
Rate of mortality
Description
Number of children dying during trial
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Rate of recovery from Moderate Acute Malnutrition in 1st group
Description
Proportion of children who reach MUAC > 12.5 cm
Time Frame
3 months
Title
Number of children having diarrhoea and acute respiratory infection during trial
Time Frame
3 months
Title
Number of children not coming for follow up visits due to any reason
Time Frame
3 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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zahra Khan, PhD
Organizational Affiliation
IRMNCH & Nutrition Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Children's Hospital & The Institute of Child Health
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition

We'll reach out to this number within 24 hrs