- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323059
Effectiveness, Tolerability and Safety of Three Formulations in Underfives With Moderate Acute Malnutrition
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
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Ekong E Udoh, FWACPaed
- Phone Number: +234(0)38355559
- Email: rejoicerejoice2001@yahoo.com
Study Contact Backup
- Name: Sunday B Adesina
- Phone Number: +234(0)8035036479
- Email: adesinasunday08@gmail.com
Study Locations
-
-
Akwa Ibom
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Ibiono Ibom, Akwa Ibom, Nigeria
- Primary Health Centre, Okpoediuse
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Contact:
- Edo Asuquo
- Phone Number: +234(0)7064559257
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Contact:
- Anietie Ekwere
- Phone Number: +234(7)089721411
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Principal Investigator:
- Ekong E Udoh, MBBS, FWACPaed
-
Sub-Investigator:
- Victor E Bassey, BSc, PhD
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Uruan, Akwa Ibom, Nigeria
- Primary Health Centre, Adadiah
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Contact:
- Christiana F Ekpeyong
- Phone Number: +234(0)8067685745
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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
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Principal Investigator:
- Ekong E Udoh, FWACPaed
-
Sub-Investigator:
- Sunday B Adesina, FWACPaed
-
Contact:
- Eneawan Edem
- Phone Number: +234(0)8028457047
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Contact:
- Victoria Usen
- Phone Number: +234(0)7030227955
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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).
- 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:
- 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}
- Children with feeding difficulties eg. Gastroesophageal reflux diseases, cleft palate
- Children with diarrhoea
- Children with neurological diseases eg. Cerebral palsy
- Children less than 6 months or more 59 months of age
Study Plan
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:
|
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:
|
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:
|
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
Sponsor
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
General Publications
- Seetharaman N, Chacko TV, Shankar SLR, Matthew AC. Measuring malnutrition - the roles of Z scores and the composite index of anthropometric failure. Indian Journal of Community Medicine. 2007; 32 (1): 35-39.
- Vijay DW, Bhawesh RD. Ready to use therapeutic food (RUTF): An overview.. Advances in life Sciences and Health. 2015; 2 (1): 1-15.
- Choudhury N, Ahmed T, Hossain MI, Islam MM, Sarker SA, Zeilani M, Clemens JD. Ready-to-Use Therapeutic Food Made From Locally Available Food Ingredients Is Well Accepted by Children Having Severe Acute Malnutrition in Bangladesh. Food Nutr Bull. 2018 Mar;39(1):116-126. doi: 10.1177/0379572117743929. Epub 2017 Dec 19.
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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