Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition

NCT04045249 | Completed DMC

• 1 other identifier: RUTF18
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Malnutrition, Child

Keywords

Malnutrition; RUTF; Children; Home base food

Outcome Measures

Primary Outcomes (6)

• Growth velocity

  Weight in Kg

  3 months

• Growth velocity

  Height in cm

  3 months

• Growth velocity

  Mid Upper Arm Circumference (MUAC) in cm

  3 months

• Duration of recovery from SAM

  Time required each child to reach MUAC \> 11.5

  3 months

• Rate of relapse

  Number of children relapsed during the trial

  3 months

• Rate of mortality

  Number of children dying during trial

  3 months

Secondary Outcomes (3)

• Rate of recovery from Moderate Acute Malnutrition in 1st group

  3 months

• Number of children having diarrhoea and acute respiratory infection during trial

  3 months

• Number of children not coming for follow up visits due to any reason

  3 months

Study Arms (3)

1st Group

NO INTERVENTION

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

2nd Group (1st Intervention group)

EXPERIMENTAL

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

Dietary Supplement: Home based food

3rd Group (2nd Intervention)

EXPERIMENTAL

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

Dietary Supplement: Home based food

Interventions

Home based food DIETARY_SUPPLEMENT

Home based food is compare able to RUTF

2nd Group (1st Intervention group); 3rd Group (2nd Intervention)

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children 6-59 months with MUAC \<11.5cm and Weight for Height Z score \< -3SD
• Having good appetite, alert and clinically well

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrated Reproductive Maternal Newborn & Child Health and Nutrition Program, Punjab: lead

Study Sites (1)

The Children's Hospital & The Institute of Child Health

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Child Nutrition Disorders; Malnutrition

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Zahra Khan, PhD

  IRMNCH & Nutrition Program

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: August 5, 2019
• Study Start: December 10, 2018
• Primary Completion: April 25, 2019
• Study Completion: April 25, 2019
• Last Updated: August 5, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)