Effectiveness Trial of Locally Developed Ready to Use Therapeutic Food

NCT05520879 | Unknown DMC

• 1 other identifier: PR-21014
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Severe Acute Malnutrition; Local RUTF; Effectiveness Trial; Forcibly Displaced Myanmar Nationals; Bangladesh

Outcome Measures

Primary Outcomes (1)

• Proportion of children graduating from SAM to non-acute malnutrition status

  The primary outcome variable is to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2 for two consecutive weeks) by 90 days of intervention

  90 days

Secondary Outcomes (12)

• Time (days) required to graduate from SAM to non-acute malnutrition status

  90 days

• Rate of weight gain of children (g/kg per day) during 1st 2 weeks, 1st 4 weeks and up to graduation

  90 days

• Proportion of children recovered (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2) by different time periods

  90 days

• Changes in weight

  90 days

• Changes in Mid Upper Arm Circumference (MUAC)

  90 days

Study Arms (2)

To provide Sharnali-1 to severe acute malnourished children

EXPERIMENTAL

We will provide Sharnali-1 among 225 severe acute malnourished children to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2 for two consecutive weeks) by 90 days of intervention.

Dietary Supplement: Sharnali 1

To provide Sharnali-2 to severe acute malnourished children

EXPERIMENTAL

We will provide Sharnali-2 among 225 severely acute malnourished children to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2 for two consecutive weeks) by 90 days of intervention.

Dietary Supplement: Sharnali 2

Interventions

Sharnali 1 DIETARY_SUPPLEMENT

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.

To provide Sharnali-1 to severe acute malnourished children

Sharnali 2 DIETARY_SUPPLEMENT

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

To provide Sharnali-2 to severe acute malnourished children

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Severe acute malnourished children
• Age 6-59 months
• Either sex
• No medical complication
• MUAC \<115 mm and/or WLZ/WHZ \<-3.

You may not qualify if:

• Children not suffering from severe acute malnutrition
• Children with oedematous malnutrition
• Failed to obtain consent for study participation from parents or legal guardian
• Suffering from any chronic illness(es) etc.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead
• UNICEF: collaborator

Study Sites (2)

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Teknāf, Cox's Bazar, Bangladesh

Location

International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b)

Ukhiya, Cox's Bazar, Bangladesh

Location

MeSH Terms

Conditions

Severe Acute Malnutrition

Condition Hierarchy (Ancestors)

Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Officials

• Md Munirul Islam, PhD

  Scientist

  STUDY DIRECTOR

• Nurun Nahar Naila, MPH

  Assistant Scientist

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Salam Khan

CONTACT

+880-2-9827001-10; salamk@icddrb.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention study products will be packaged in sachets that cannot be differentiated between the two.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sharnali-1 and Sharnali-2 would be provided among 450 severely acute malnourished children divided into two groups to assess the proportion of children graduating from SAM to non-acute malnutrition status (MUAC ≥ 125 mm or WLZ/WHZ ≥ -2 for two consecutive weeks) by 90 days of intervention.

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: August 30, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: December 21, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (2)