NCT04715204

Brief Summary

The primary outcome of the study is to identify gastrointestinal tolerance of under-five children with severe acute malnutrition to ready-to-drink high energy (1.5 kcal/ml) and standard energy (1 kcal/ml) oral nutrition supplement (ONS) compared to Formula-75/Formula-100. The secondary outcomes of the study are weight gain, electrolyte profile and plasma amino acid profile at the beginning and the end of stabilization phase. In this randomized, controlled trial, 108 patients with severe acute malnutrition will be enrolled. Patients are randomly assigned to 3 groups (Formula-75/Formula-100, high energy ONS, and standard energy ONS) to undergo a two-week treatment. In order to ensure an adequate intake, nasogastric-tube will be placed for home enteral nutrition for at least throughout the two-week study period. Parent or caregiver will be asked to record daily intake, vomit, and defecation score using Bristol stool chart.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

2 active sites

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

September 4, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2021

Completed
Last Updated

December 2, 2021

Status Verified

December 1, 2021

Enrollment Period

1.6 years

First QC Date

January 12, 2021

Last Update Submit

December 1, 2021

Conditions

Severe Acute Malnutrition

Keywords

severe acute malnutritionoral nutrition supplementFormula-75/Formula-100Under-five children

Outcome Measures

Primary Outcomes (2)

  • Gastrointestinal tolerance for bowel movement

    Frequency of bowel movement per day and description of stool consistency (Bristol stool chart)

    14 days

  • Gastrointestinal tolerance for vomit

    Frequency of vomit per day and volume of vomit

    14 days

Secondary Outcomes (6)

  • Weight gain

    14 days

  • Height gain

    14 days

  • Prevalence of hypokalemia

    Day 1 and day 3

  • Prevalence of hypophosphatemia

    Day 1 and day 3

  • Prevalence of hypomagnesemia

    Day 1 and day 3

  • +1 more secondary outcomes

Study Arms (3)

Formula-75/Formula-100

ACTIVE COMPARATOR

This arm is the control. Formula-75/Formula-100 are the standard formula recommended by WHO to treat severely malnourished children.

Other: Formula-75/Formula-100

High Energy Oral Nutrition Supplement

EXPERIMENTAL

High energy oral nutrition supplement (ONS) has energy density of 1.5 kcal/ml, with protein-energy ratio of 8.9% and complete micronutrients. It is also named as enteral formula and can be used as a sole source of nutrition. It comes as a ready-to-drink bottled package of 200 mL each. The nutrition fact fulfills the requirement of BPOM (Indonesian Food and Drug Authority) for Special Medical Purpose. The ready-to-drink formula is a safe option to treat severely malnourished patient in terms of hygiene assurance of formula. In Indonesia, many severely malnourished children come from areas with poor access to clean water and proper sanitation. The high energy ONS is beneficial for children who cannot tolerate large volume of feeding.

Other: High Energy Oral Nutrition Supplement

Standard Energy Oral Nutrition Supplement

EXPERIMENTAL

Standard energy oral nutrition supplement (ONS) has energy density of 1 kcal/ml, with protein-energy ratio of 9.6% and complete micronutrients. It is also named as enteral formula and can be used as a sole source of nutrition. It comes as a ready-to-drink bottled package of 200 mL each. The nutrition fact fulfills the requirement of BPOM (Indonesian Food and Drug Authority) for Special Medical Purpose. The ready-to-drink formula is a safe option to treat severely malnourished patient in terms of hygiene assurance of formula. In Indonesia, many severely malnourished children come from areas with poor access to clean water and proper sanitation.

Other: Standard Energy Oral Nutrition Supplement

Interventions

High Energy Oral Nutrition SupplementOTHER

Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density \>0.9 kcal/mL. Formula with caloric density of \>1.2 kcal/mL is categorized as high energy ONS. This intervention has caloric density of 1.5 kcal/mL.

Also known as: High Energy ONS
High Energy Oral Nutrition Supplement
Standard Energy Oral Nutrition SupplementOTHER

Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density \>0.9 kcal/mL. This intervention has caloric density of 1 kcal/mL and it is categorized as standard energy ONS.

Also known as: Standard Energy ONS
Standard Energy Oral Nutrition Supplement
Formula-75/Formula-100OTHER

Formula-75/Formula-100 is a special therapeutic foods to treat children with severe acute malnutrition. WHO designed F75 as a starter formula for stabilization phase with 75 kcal/100 mL, then it is continued with F100 for rehabilitation phase with 100 kcal/100 mL Formula-75 and Formula-100 are made according to recipe from WHO. The ingredients are skimmed milk powder, coconut oil, and sugar. Mineral mix is added, i.e. 2 ml every 100 ml of formula. The composition of F-75: Skimmed milk 25 g, coconut oil 100 g, sugar 30 g, mineral mix 20 ml, add water to 1000 ml The composition of F-100: Skimmed milk 80 g, coconut oil 50 g, sugar 60 g, mineral mix 20 ml, add water to 1000 ml

Also known as: F75/F100
Formula-75/Formula-100

Eligibility Criteria

Age12 Months - 60 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 12-60 months
  • Weight for length/height z score \< -3 (WHO 2006)
  • Not on nutritional treatment of severe acute malnutrition for the last 1 month

You may not qualify if:

  • Not willing to take part in this study
  • Having diarrhea
  • Diagnosed with malignancy or suspected malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RSUPN Dr. Cipto Mangunkusumo

Jakarta, DKI Jakarta, 10430, Indonesia

Location

RSUP Fatmawati

Jakarta, DKI Jakarta, 12430, Indonesia

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Klara Yuliarti, MD

    Department of Pediatric, Faculty of Medicine, University of Indonesia/ Cipto Mangunkusumo Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 12, 2021

First Posted

January 20, 2021

Study Start

September 4, 2019

Primary Completion

April 15, 2021

Study Completion

April 15, 2021

Last Updated

December 2, 2021

Record last verified: 2021-12

Locations

ID(2)