Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202310531950135 Date of Approval: 16/10/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Rice-soy blend with nutrition counselling versus nutrition counselling alone in the management of moderate acute malnutrition in under-fives in Akwa-Ibom state, Nigeria.
Official scientific title Evaluation of a locally-formulated supplementary feeds with nutrition counselling versus nutrition counselling alone in the management of moderate acute malnutrition in under-fives in Akwa-Ibom state, Nigeria.
Brief summary describing the background and objectives of the trial Childhood malnutrition is a leading cause of under-five morbidity and mortality globally. The condition is associated with impaired physical, neurologic, immunologic and metabolic development. The condition often results from poverty, household food insecurity and poor infant and young child feeding practices and children below two years of age are the most vulnerable. Malnutrition can be classified as underweight (weight-for-age Z score < -2), stunting (height-for-age Z score <-2), wasting (weight-for-height Z score < -2) in relation to WHO standard reference. Moderate acute malnutrition (MAM) is defined by Z score between -2 and -3 SD with Mid upper arm circumference (MUAC) of 11.5 cm – 12.5 cm. Children with MAM could progress severe acute malnutrition (Z score is <-3) with MUAC of < 11.5 cm. Most malnutrition-related deaths occur in children with MAM. The management of MAM is based on nutrition education use of home-based nutritional formulations prepared from locally available food stuffs and ready-to-use therapeutic foods (RUTFs). RUTFs are usually provided by donor agencies for programmatic purpose and as such not a sustainable approach to addressing the problem of childhood malnutrition in endemic settings. It becomes imperative to intensify nutrition counselling and develop effective nutritional formulations from locally available foodstuffs to effectively address this problem. A potential formulation is the standardized rice-soy blend. This clinical trial seeks to evaluate the effectiveness of supplementary dose of rice-soy blend with nutrition counselling versus nutrition counselling alone in the management of under-fives with MAM in Akwa Ibom State, Nigeria.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial screening, early diagnosis and treatment
Anticipated trial start date 02/10/2023
Actual trial start date 23/10/2023
Anticipated date of last follow up 23/04/2024
Actual Last follow-up date 30/04/2024
Anticipated target sample size (number of participants) 200
Actual target sample size (number of participants) 200
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Supplementary feeding with nutrition counselling group 1. 6 months to 12 months =525kcal X 2 feeds daily 2. 13 months to 24 months = 675kcal X 2(1/2) feeds daily 3. 25 months to 36 months = 825kcal X 3 feeds daily 4. 37 months to 48 months = 945kcal X 3(1/2) feeds daily 5. 49 months to 59 months = 1095kcal X 4 feeds daily six months The regular diet of children recruited into this group will be supplemented with the supplementary food LS-RSB at a dose that meets 50% of their daily caloric requirements based on daily caloric requirement of 120kcal/kg/day. The LS-RSB meal will be served to the children at least two to four times daily while the remaining 50% of their daily caloric need will be provided by their regular family diet based on the nutrition counselling given to the caregivers. Feeding will be done using calibrated cups for modest estimation of the volume of the feeds consumed and the leftover feeds in cases where the children are unable to finish the meal. Mothers that are still breast feeding will be encouraged to continue doing so 100
Control Group Nutrition counselling alone group 100% of regular family diet daily Nutrition counselling alone every two weeks six months The mothers/caregivers in the group will receive nutrition counselling on the appropriate age- specific practices on child nutrition every two weeks for six months. The specific messages that will be given to mothers/caregivers is contained in the key messages booklet by UNICEF - a manual on community infant and young child feeding counselling package. Messages in cards 3-18 of the manual will be used. The messages will also be interpreted in the local dialects of the people. 100 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Children aged 6-59 months with MAM (weight-for-height/age between -2 and -3 z scores or MUAC 11.5cm to 12.5cm. 2. Children whose parents/guardians’ consent to their participation and agree to bring the children/wards to the health facility throughout the period of the study. 1. Children with history of chronic illness, identified based on history and careful physical examination (cardiac disease, tuberculosis, liver disease, renal disease, HIV/AIDS, sickle cell diseases). 2. Children with feeding difficulties (gastroesophageal reflux disease, cleft palate). 3. Children with neurological diseases such as cerebral palsy due to associated developmental delays. Cerebral palsy also affects the muscles and movements involved in chewing and swallowing, which impairs the child’s ability to safely consume food necessary to support growth. Infant: 13 Month(s)-24 Month(s),Preschool Child: 2 Year-5 Year 6 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 17/05/2023 Akwa Ibom State Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Department of Planning, Research and Studies, ministry of Health, Idongesit Nkanga Secretariat Uyo 520101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 1. Recovery from MAM 2. Time to recovery from MAM Outcome measures will be taken at two weekly intervals for a period of six months
Secondary Outcome Suitability of rise-soy blend Outcome measures will be taken at two weekly intervals for a period of six months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary Health Center Mbiabong Etoi Mbiabong Etoi, off Timber market, Uyo. Akwa Ibom state Uyo 520101 Nigeria
Primary Health Center West Itam Along Calabar-Itu high way, Itam, Akwa Ibom state. Itam 520108 Nigeria
Health Post Ikot Edong Ekpat Idout, Abak local government area, Abak, Akwa Ibom state. Abak town 532101 Nigeria
Primary Health Center Ibiaku Ntok Okpo Ibiaku, Ikono local government area, Akwa Ibom state Ibiaku 520107 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Rosemary Augustine Umoh Department of Paediatrics, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State. Uyo 520101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dr Rosemary Augustine Umoh Department of Paediatrics, University of Uyo Teaching Hospital, Uyo, Akwa Ibom State. Uyo 520101 Nigeria Hospital
Secondary Sponsor Professor Augustine Vincent Umoh Department of Obstetrics and Gynaecology. University of Uyo Teachinh Hospital, Uyo. Akwa Ibom state. Uyo 520101 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Professor Augustine Vincent Umoh Department of Obstetrics and Gynaecology, University of uyo Teaching Hospital, Uyo, Akwa Ibom state. Uyo 520101 Nigeria
Dr Ekong Emmanuel Udoh Department of Paediatrics, University of Uyo Teaching Hospital, Uyo, Akwa Ibom state. Uyo 520101 Nigeria
Dr Ofonime Dixon umoh Department of Paediatics, University of Uyo Teaching Hospital, Uyo, Akwa Ibom state Uyo 520101 Nigeria
Dr Peter Essien General Hospial Ikpe Annang Ikot Ekpene 530101 Nigeria
Dr Victor Effiong Bassey Nutrition Unit, Ministry of Health, Akwa Ibom state. Uyo 520101 Nigeria
Blessing Utuk affiah Nutrition Unit, Ministry of Health, Akwa Ibom state. Uyo 520101 Nigeria
Dr Uduakobong Adiaden General Hospital Ikpe Annang Ikot Ekpene 530101 Nigeria
Dr Emmanuel Edward Department of Public Health University of Uyo Teaching Hospital, Uyo, Akwa Ibom state. Uyo 520101 Nigeria
Uduak Ekerette Gilbert PHC, OP Base Ikono Ikot Ekpene 520102 Nigeria
Ms. Blessing N. Nwazuluoke Dietetic Unit Internal Medicine Department University of Uyo Teaching Hospital, Uyo, Akwa Ibom State. Nigeria Uyo 520101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Rosemary Umoh rosemaryumoh75@gmail.com +2348038757222 Department of Paediatrics, University of Uyo Teaching Hospital, Uyo, Akwa Ibom state
City Postal code Country Position/Affiliation
Uyo 520101 Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries Blessing Affiah blessingaffiah@gmail.com +2347036869798 Nutrition Unit, Ministry of Health, Akwa Ibom state.
City Postal code Country Position/Affiliation
Uyo 520101 Nigeria Nutritionist
Role Name Email Phone Street address
Scientific Enquiries Ekong Udoh rejoicerejoice2001@yahoo.com +2348038355559 Department of Paediatics, University of Uyo Teaching Hospital, Uyo. Akwa Ibom state
City Postal code Country Position/Affiliation
Uyo 520101 Nigeria Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Yes, i will be sharing my individual participant data. Individual participant data will be shared by the Principal Investigator on request. Additional documents such as Study protocol, Informed consent, Clinical study report, Statistical analysis plan and Analytic code will be made available by the Principal Investigation upon request. Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 36 months following article publication. Extensions will be considered on a case-by-case basis Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan and execution of a Data Sharing Agreement. To gain access, proposals should be directed to my email. Data requestors will need to sign a data access agreement. For more information or to submit a request, please contact rosemaryumoh75@gmaill.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information