Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition

March 26, 2020 updated by: Dr. Ekong E. Udoh

Effectiveness, Tolerability and Safety of Standardized Milk-based, Standardized Non-milk Based and Hospital-based Formulations in the Management of Moderate Acute Malnutrition in Underfive Children: A Randomized Clinical Trial

This is a randomized clinical trial aimed at evaluating the effectiveness, tolerability and safety of standardized milk-based formulation, standardized non-milk based formulation and a hospital-based formulation in the management of children aged 6 - 59 months with moderate acute malnutrition. Eligible children will be randomized into one of the three intervention arms and given supplementary doses of the formulations at 50% of their daily caloric requirement for a period of four months based on the group of their assignment. The remainder will be obtained from their regular family diets. The clinical features, anthropometric measurements and laboratory parameters of the children will be assessed at baseline. The children will be followed up on two weekly basis for a period of four months during which further clinical assessment, anthropometric measurements and laboratory evaluations will be performed. The outcome measures will be determined based on "per protocol analysis".

Study Overview

Detailed Description

Childhood malnutrition is presently a leading cause of underfive morbidity and mortality globally. The impact of the condition is most severe in the first 1000 days of life with resultant impairment in physical, neurologic, immunologic and metabolic development.

Undernutrition, the commoner form of childhood malnutrition, is usually classified as underweight (weight-for-age Z score < -2), stunting (height-for-age Z score <-2), wasting (weight-for-height Z score < -2) or edematous malnutrition (kwashiorkor) in relation to the World Health Organization standard reference values for age and sex. It is further sub-classified into severe acute malnutrition (SAM) wherein z score is <-3 and moderate acute malnutrition (MAM) wherein z score is between -2 and -3.(1) MAM accounts for about 70.0% of all malnutrition-related childhood deaths.

Children with MAM are currently managed using community-based approach. This approach entails early detection and treatment of children with MAM in the community, timely referral to inpatient care for those that progress to SAM or develop complications, and subsequent follow up in the community at discharge. MAM is usually managed by nutrition education of the caregivers on preparation of nutritious, palatable and culturally acceptable food from locally available food stuffs like banana porridge or corn gruel fortified with legume (mashed groundnut or soya bean), crayfish, palm oil, powdered milk and vegetables. The second strategy is by Ready-to-use therapeutic foods (RUTFs). (2) The main drawback of the RUTFs is that they are usually provided by external donor agencies and as such, not always available in settings where childhood malnutrition is endemic. Children treated with RUTFs are therefore at risk of progressing to SAM or dying when the formulations are no longer available. There is currently no consensus on the appropriate nutritional formulation for community-based management of MAM in children in endemic regions. It is therefore imperative to evaluate the effect of readily available formulations that are comparable to the RUTFs in community-based management of childhood MAM in endemic regions. (3) The standardized milk-based formulation (SMBF), the standardized non milk-based formulation (SNMBF) and the hospital-based formulation (HBF) are examples of formulations that are readily available in the country. The SMBF consists of maize and is rich in methionine, the SNMBF consists of maize and soybeans, and is rich in methionine and lysine while the HBF consist of a combination of maize, milk and soybeans. The nutrient composition of the above-mentioned formulations is similar to that of the RUTFs, making them suitable for community-based management of MAM. However, no clinical trial has so far been conducted to evaluate their effect in managing underfive children with MAM. The cost effectiveness of the various formulations will also be assessed.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Akwa Ibom
      • Ibiono Ibom, Akwa Ibom, Nigeria
        • Primary Health Centre, Okpoediuse
        • Contact:
          • Edo Asuquo
          • Phone Number: +234(0)7064559257
        • Contact:
          • Anietie Ekwere
          • Phone Number: +234(7)089721411
        • Principal Investigator:
          • Ekong E Udoh, MBBS, FWACPaed
        • Sub-Investigator:
          • Victor E Bassey, BSc, PhD
      • Uruan, Akwa Ibom, Nigeria
        • Primary Health Centre, Adadiah
        • Contact:
          • Christiana F Ekpeyong
          • Phone Number: +234(0)8067685745
        • Contact:
          • Okon Asuquo
          • Phone Number: +234(0)7063384541
        • Principal Investigator:
          • Ekong E Udoh, FWACPaed
        • Sub-Investigator:
          • Sunday B Adesina, FWACPaed
      • Uyo, Akwa Ibom, Nigeria
        • Primary Health centre, Mbak-Etoi
        • Principal Investigator:
          • Ekong E Udoh, FWACPaed
        • Sub-Investigator:
          • Sunday B Adesina, FWACPaed
        • Contact:
          • Eneawan Edem
          • Phone Number: +234(0)8028457047
        • Contact:
          • Victoria Usen
          • Phone Number: +234(0)7030227955

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 4 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Children aged 6 - 59 months with moderate acute malnutrition (weight-for-height between -2 and -3 Z scores or mid upper arm circumference of 11.5 cm - 12.5 cm).
  2. Children whose parents/guardian consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study.

Exclusion Criteria:

  1. Children with chronic illnesses that may affect growth {(cardiac disease, renal disease, tuberculosis (chronic cough, history of contact with an adult with chronic cough, poor growth, chest infection not responding to antibiotics) liver disease, HIV/AIDS}
  2. Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
  3. Children with diarrhoea
  4. Children with neurological diseases eg. Cerebral palsy
  5. Children less than 6 months or more 59 months of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Standardized milk-based formulation
Formulation of maize with milk that is rich in methionine
Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
Other Names:
  • Standardized non-milk based formulation
  • Hospital-based formulation
EXPERIMENTAL: Standardized non-milk based formulation
Formulation of maize with soybeans that is rich in methionine and lysine
Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
Other Names:
  • Standardized non-milk based formulation
  • Hospital-based formulation
ACTIVE_COMPARATOR: Hospital-based formulation
Formulation of maize, milk and soybeans
Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
Other Names:
  • Standardized non-milk based formulation
  • Hospital-based formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weight-for-height
Time Frame: Four months
Improvement in weight-for-height at two weekly intervals
Four months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery from moderate acute malnutrition
Time Frame: Four month
Proportion of children whose weight-for-height z score improved from <-2 to ≥ 2
Four month
Adverse events
Time Frame: Four months
The number of children that develop and undesirable gastrointestinal or extraintestinal disorder
Four months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Ekong E Udoh, FWACPaed, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
  • Study Director: Sunday B Adesina, FWACPaed, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria
  • Study Chair: Blessing N Nwazuluoke, BSc, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State, Nigeria

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

November 1, 2020

Study Registration Dates

First Submitted

March 24, 2020

First Submitted That Met QC Criteria

March 24, 2020

First Posted (ACTUAL)

March 26, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 30, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UUTH/AD/S/96/VOL.XXI/341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data will be made available to other researchers by the Principal Investigator on request.

IPD Sharing Time Frame

The data will be available for two years after completion of the trial

IPD Sharing Access Criteria

Any investigator that request for it within the time frame will be given

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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