Comparison of Different Feeding Protocols for the Treatment of Acute Malnutrition

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2019-04-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Alternative Feeding Regimen on Recovery of Children Aged 6-59 Months With Moderate Acute Malnutrition in Bangladesh.

NCT06045104

Moderate Acute Malnutrition

UNKNOWN NA

Optimization of the Simplified Protocol in Mali: a Cluster Randomised Pragmatic Trial

NCT06594341

Acute Malnutrition in Infancy Acute Malnutrition in Childhood Acute Malnutrition, Severe

COMPLETED PHASE4

Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition

NCT04323059

Malnutrition; Moderate

UNKNOWN PHASE4

Effectiveness of LNS and MNP Supplements to Prevent Malnutrition in Women and Their Children in Bangladesh

NCT01715038

Malnutrition

COMPLETED NA

Appropriate Complmentary Feeding Strategies in Infants

NCT01412411

Anemia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malnutrition, Child

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1st Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Home based food

Intervention Type DIETARY_SUPPLEMENT

Home based food is compare able to RUTF

3rd Group (2nd Intervention)

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

Group Type EXPERIMENTAL

Home based food

Intervention Type DIETARY_SUPPLEMENT

Home based food is compare able to RUTF

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Home based food

Home based food is compare able to RUTF

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Months

Maximum Eligible Age

59 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No