NCT04667767

Brief Summary

This study evaluates the addition of a simple, scalable "WASH kit", including household water treatment products, a safe water storage container, and hygiene promotion, to the standard national protocol for outpatient treatment of uncomplicated severe acute malnutrition among children aged 6-59 months of age in northern Senegal.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,411

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

December 8, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2023

Completed
Last Updated

January 25, 2024

Status Verified

January 1, 2024

Enrollment Period

2.3 years

First QC Date

December 8, 2020

Last Update Submit

January 24, 2024

Conditions

Severe Acute Malnutrition

Outcome Measures

Primary Outcomes (1)

  • Rate of recovery

    Recovery defined as two consecutive weeks with weight-for-height z-scores ≥ -1.5, if admitted based on weight-for-height z-score, or brachial perimeter (mid-upper arm circumference) ≥ 125 mm, if admitted based on brachial perimeter, and no oedema.

    8 weeks

Secondary Outcomes (5)

  • Weight gain

    8 weeks

  • Rate of referral

    8 weeks

  • Longitudinal prevalence of diarrhoea

    8 weeks

  • Prevalence of enteric pathogen detection

    8 weeks

  • All cause mortality

    8 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

In addition to the national standard outpatient treatment for uncomplicated severe acute malnutrition, caregivers of participants will receive a "WASH kit" containing a plastic container, a supply of Aquatabs® (effervescent chlorine tablets), and training in their use and associated hygiene practices.

Other: WASH kit

Control

ACTIVE COMPARATOR

National standard outpatient treatment for uncomplicated severe acute malnutrition

Other: Standard treatment

Interventions

WASH kitOTHER

WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.

Intervention
Standard treatmentOTHER

National standard outpatient treatment for uncomplicated severe acute malnutrition

Control

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Weight-for-height z-score \<-3; or
  • Brachial perimeter (mid-upper arm circumference) \<115; or
  • Bilateral oedema

You may not qualify if:

  • Not able and/or willing to participate for up to 8-weeks
  • Clinical complications requiring referral and/or inpatient treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ACF Senegal

Louga, Senegal

Location

Related Publications (1)

  • N'Diaye DS, Frison S, Ba M, Le ML, Cabo AE, Siroma F, Devort A, MacLeod C, Lapegue J, Seye M, Traore AB, Cerveau T, Leger D, Gallandat K, Gnokane Y, Brizuela AV, Stern S, Braun L, Cumming O. Implementing a pragmatic randomised controlled trial in a humanitarian setting: lessons learned from the TISA trial. Trials. 2024 Sep 19;25(1):620. doi: 10.1186/s13063-024-08459-1.

    PMID: 39300465DERIVED

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

MalnutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Oliver Cumming, MSc

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Dieynaba N'Diaye, PhD

    Action Contre La Faim - France

    PRINCIPAL INVESTIGATOR

  • Moustapha Seye, PhD

    Université Cheikh Anta Diop de Dakar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2020

First Posted

December 16, 2020

Study Start

December 22, 2020

Primary Completion

April 27, 2023

Study Completion

April 27, 2023

Last Updated

January 25, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

All IPD that underlie results in a publication will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
December 2022
Access Criteria
All IPD that underlie results will be made publicly available

Locations

SE(1)