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NCT05543759
Simplified Treatment Protocol for Acute Malnutrition in Venezuela
trial testing Ready-To-Use Therapeutic Food (RUTF) in Acute Malnutrition in Childhood in 307 participants. Terminated before completion.
30 November 2022
Quick facts
| Lead sponsor | UNICEF - Venezuela |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 307 |
| Start date | 5 September 2022 |
| Primary completion | 30 November 2022 |
| Estimated completion | 30 November 2022 |
| Sites | 1 location across Venezuela |
Drugs / interventions tested
- Ready-To-Use Therapeutic Food (RUTF)
Conditions studied
- Acute Malnutrition in Childhood — all drugs for Acute Malnutrition in Childhood →
- Wasting — all drugs for Wasting →
- Child Malnutrition — all drugs for Child Malnutrition →
Sponsor
UNICEF - Venezuela
Who can join
Adults 6 Months to 59 Months, any sex, with Acute Malnutrition in Childhood or Wasting. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Related trials
Other recruiting trials for Acute Malnutrition in Childhood
Currently open trials in the same condition.
- NCT06599593 — Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition · NA · active not recruiting
Other UNICEF - Venezuela trials
Trials by the same sponsor.
- NCT06287827 — Treatment of Acute Malnutrition in Outpatient Care Services in Venezuela: a Prospective Cohort Research · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05543759 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by UNICEF - Venezuela
- Last refreshed: 10 May 2023
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing