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Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food

NCT05520879 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 450

Last updated 2022-12-21

No results posted yet for this study

Summary

As poor health conditions and malnutrition are major issues confronting the influx of Forcibly Displaced Myanmar Nationals (FDMN), there is an urgent need to prepare the service providers to control the situation and to prevent deaths and disabilities in FDMN children suffering from severe acute malnutrition (SAM). It is therefore imperative to assess the effectiveness of the two local Nutrition Managements (NMs); Sharnali 1 \& Sharnali 2 for the treatment of SAM in an emergency in Bangladesh.

If the effectiveness trial shows that the NMs are effective, either one or both varieties can be used for children with SAM in emergency situations. Ultimately a Bangladeshi solution will replace the expensive RUTF that is currently being imported for use in the FDMN camps for management of SAM.

Conditions

  • Malnutrition Severe

Interventions

DIETARY_SUPPLEMENT

Sharnali 1

The intervention is food product, made from locally available food ingredients in Bangladesh. Sharnali 1 made from rice, lentil, dried skimmed milk, sugar, vegetable oils and micronutrient premix.

DIETARY_SUPPLEMENT

Sharnali 2

Sharnali 2 made from chick peas, dried skimmed milk, sugar, vegetable oils and micronutrient premix.

Sponsors & Collaborators

  • UNICEF

    collaborator OTHER

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Principal Investigators

  • Md Munirul Islam, PhD · Scientist

  • Nurun Nahar Naila, MPH · Assistant Scientist

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2024-12-31
Completion
2024-12-31

Countries

  • Bangladesh

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 NCT05520879 on ClinicalTrials.gov