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Simplified Treatment Protocol for Acute Malnutrition in Venezuela

NCT05543759 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 307

Last updated 2023-05-10

No results posted yet for this study

Summary

Global acute malnutrition (GAM) in children under five is defined by being too thin for a given height and/or having the Mid-upper arm circumference less than a given threshold. GAM includes moderate acute malnutrition (MAM) and severe acute malnutrition (SAM). This study has been designed to generate new evidence about the simplified combined protocol for the identification and treatment of GAM in Venezuela. The objective of the study is to document the safety and effectiveness of the Venezuelan simplified treatment protocol for GAM, which includes reduced frequency of follow-up visits, single product use and optimized daily RUTF dose. This prospective longitudinal study was conducted in 19 centers treating GAM in children aged 6-59 months diagnosed with uncomplicated GAM, defined as WHZ \<-2 or MUAC \<125mm or ++ bilateral edema. Children will be prospectively followed for a total of 6 months, including the treatment phase and the immediate post-discharge weeks until 6 months. The effectiveness of the treatment will be measured by the recovery rate, duration of the treatment and changes in anthropometry (weight, height and arm circumference). Other treatment effects will also be measured, including how many are admitted to the hospital, death and relapse rates from the nutritional program. An economic evaluation component will be incorporated. Total costs will be aggregated and presented as costs per child treated and per child recovered.

Conditions

  • Acute Malnutrition in Childhood
  • Wasting
  • Child Malnutrition

Interventions

DIETARY_SUPPLEMENT

Ready-To-Use Therapeutic Food (RUTF)

* SAM \[MUAC \<115mm or WHZ \<-3 or oedema (+/++)\] = Two 92g sachets RUTF/day (Approx. 1000 kcal/day). * MAM \[MUAC 115mm\<125mm or WHZ \<-2\] = One 92g sachet RUTF/day (Approx. 500 kcal/day).

Sponsors & Collaborators

  • UNICEF - Venezuela

    lead OTHER

Principal Investigators

  • Zulay Gonzalez, MSc · UNICEF - Venezuela

Eligibility

Min Age
6 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-05
Primary Completion
2022-11-30
Completion
2022-11-30

Countries

  • Venezuela

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05543759 on ClinicalTrials.gov