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.: PACTR202002462358066 Date of Approval: 18/02/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Standardized Corn-Soy Blend with Nutrition Education versus Nutrition Education Alone in Community-based Management of Children Under Five Years of Age with Moderate Acute Malnutrition
Official scientific title Standardized Corn-Soy Blend with Nutrition Education versus Nutrition Education Alone in Community-based Management of Children Under Five Years of Age with Moderate Acute Malnutrition: A Randomized Controlled Clinical Trial
Brief summary describing the background and objectives of the trial Childhood malnutrition results from qualitative and quantitative deficiency and imbalance of dietary nutrients with resultant impaired physical, neurologic, immunologic and metabolic development. The adverse effect of malnutrition in children is greatest in the first 1000days. Poverty, household food insecurity and ignorance of caregivers on infant and young child feeding practices are the major risk factors for the condition in developing countries. It 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) or edematous malnutrition (kwashiorkor) in relation WHO standard reference values. It is further sub-categorized into severe acute malnutrition (Z score is <-3) or moderate acute malnutrition (MAM) if the Z score is between -2 and -3. 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). The major drawback of RUTFs is that they are usually provided by donor agencies for programmatic purpose and as such not sustainable in settings where childhood malnutrition is endemic. It becomes imperative to develop effective nutritional formulations from locally available foodstuffs that are readily available, accessible, affordable, culturally acceptable and sustainable for managing MAM. One such formulation is the standardized corn-soy blend mix. This clinical trial seeks to evaluate the effectiveness of supplementary dose of corn-soy blend with nutrition education versus nutrition education alone in the management of underfives 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 Treatment: Other
Anticipated trial start date 02/03/2020
Actual trial start date
Anticipated date of last follow up 30/11/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants)
Recruitment status Not yet 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 Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Nutrition education alone Two weekly nutrition education of caregivers on infant and young child feeding practices at two weekly intervals Six months Regular nutrition education using pictorial flip charts would be given to caregivers with the key message on the importance of exclusive breast feeding in the first six months of life and continuation of breast feeding up the age of two years. Education on the different food classes, how to prepare appropriate complementary feed from locally available food stuff and appropriate time for initiation of complementary feeds, adequacy and frequency of feeding based on age-specific need of the child. 80 Active-Treatment of Control Group
Experimental Group Standardized corn soy blend with nutrition education Administration standardized corn soy blend at 50% of the daily caloric requirement of children along with nutrition education of their caregivers at two weekly intervals. Intervention would be given for six months Standardized corn soy blend will consist of corn gruel fortified with soy beans, powdered milk, vegetable oil and mineral mix along with nutrition education. 80
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 11.5 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. 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 diarrhea (history of passage of ≥ 3 loose stools/day), signs of dehydration or loss of appetite will be considered as complication of malnutrition. 4. Children with neurological diseases eg. Cerebral palsy 5. Children less than 6 months or more 59 months of age 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 18/11/2019 University of Uyo Teaching Hospital Uyo Institutional Health Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
323 Abak Road Uyo 520221 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To determine the; • Improvement from baseline of weight-for-height at two weekly intervals for six months follow-up duration. • The compare the proportion of recovery from MAM in the intervention arm versus the control arm. Two weekly intervals from baseline till end of the study
Secondary Outcome To determine the; • Change in mid upper arm circumference from baseline • The proportion of non-recovery from MAM • Time-to-recovery from MAM • Time-to-progression from MAM to SAM • Change in serum protein from baseline • Change in haematocrit value from baseline • Change in serum electrolyte, urea and creatinine values from baseline • All-cause- mortality Adverse events Baseline and at end of the study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Primary Health Centre Ndon Ebom Off Airport Road, Uruan Local Government Area Uruan 520107 Nigeria
Primary Health Centre Mbak Etoi Off Oron Road, Uyo Uyo 520221 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Uyo Tertiary Trust Fund Ekpa Road Uyo 520221 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Uyo Ekpa Road Uyo 520221 Nigeria University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ekong Udoh rejoicerejoice2001@yahoo.com +2348038355559 Paediartic Department, University of Uyo Teaching Hospital
City Postal code Country Position/Affiliation
Uyo 520221 Nigeria Consultant of Paediatric Gastroenterology University of Uyo Teaching Hospital Uyo Nigeria
Role Name Email Phone Street address
Public Enquiries Frances Okpokoworuk zipsadoo@yahoo.com +2348037270377 Paediatric Department University of Uyo Teaching Hospital
City Postal code Country Position/Affiliation
Uyo 520221 Nigeria Consultant Cardiologist University of Uyo Teaching Hospital
Role Name Email Phone Street address
Scientific Enquiries Mkpouto Akpan mkpoutoakpan@yahoo.com +2348033400714 323 Abak Road
City Postal code Country Position/Affiliation
Uyo 520221 Nigeria Consultant of Paediatric Neurology University of Uyo Teaching Hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The individual participant would be shared on request Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol It will be shared between 6 months and 2 years of completion of the study This will be based on requisition from any of the investigators
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