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: www.pactr.org
Trial no.: PACTR201809662822990 Date of Approval: 12/09/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Moderate acute malnutrition treatment
Official scientific title Treating moderate acute malnutrition: Effect of local ingredient based supplementary food in treating Moderate Acute Malnutrition among children aged 6 to 59 months in Southern Ethiopia: A randomized controlled trial.
Brief summary describing the background and objectives of the trial Introduction: Acute malnutrition is a public health problem in Ethiopia. Moderate acute malnutrition (MAM) is one form of acute malnutrition. Numerous studies have mentioned that the current management practice of MAM as it related with high rates of defaulting, high related costs, low coverage and low recovery rate. In Ethiopia, corn-soya blend plus (CSB+) is given as a supplementary food under targeted supplementary feeding program as a management of MAM but it is limited for chronically food insecure areas. Even though, treatment of MAM is a means of preventing sever acute malnutrition, the existing management is inadequate and has its own drawbacks. Besides to this, adequate research has not been conducted in Ethiopia on local ingredient based supplementary food as it has a potential to contribute in treating MAM. This study is commenced to look at the effect of local ingredient based supplementary food in treating MAM among children aged 6 to 59 months. The information drawn from this study will be shared to the public, policy makers and academicians as locally available nutritious foods have a potential to enhance recovery from MAM and reduce the burden of malnutrition. Objective: To evaluate the effect of local ingredient based supplementary food in treating moderate acute malnutrition through comparing the recovery rate from MAM in both intervention (receiving local ingredient based supplementary food) and control (getting corn-soya blend plus (CSB+) groups). Methods: In a randomized controlled Non-inferiority trial, 324 children with mid upper arm circumference of ≤11.5 cm to 12.5 cm will be recruited into the trial after informed consent. Through the recruitment process, those children seen as sever acutely malnourished will be refereed to nearby health facility. Village stratified randomization will ensure the allocation 1:1.The study subjects, parents, and data collectors will be kept uninformed about the allocation. Statistical analysis will be done using the latest SPSS version and ENA for SMART software.
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 27/07/2018
Actual trial start date 21/08/2018
Anticipated date of last follow up 22/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 324
Actual target sample size (number of participants) 324
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 Simple randomization using a randomization table created by a computer software program Numbered containers Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Local ingredient based supplementary food 100gm/day 3 month 100gm flour containing locally available food (pumpkin seed, Amaranth grain, peanut) 162
Control Group Corn with soya bean flour 100gm/day 3 month Corn-soya blend plus, 70% maize with 30% soya bean 162 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children with MAM, mid-upper arm circumference (MUAC) of ≥11.5 to 12.5 cm and/or Weight for height z scores, < -2 and ≥ -3 based on WHO growth reference and those who are currently living in the study area. Subjects who are planning to continue to live in the study area for the next 6 month. Severely malnourished children, Children with chronic illnesses or other medical complications that prevented them from safely ingesting supplementary food, Children already participating in other interventions will be excluded. Infant: 1 Month-23 Month,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 09/03/2018 University of Bergen
Ethics Committee Address
Street address City Postal code Country
281. Haukelandsveien 28 Oslo 5020 Norway
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 21/12/2017 Hawassa University College of medicine and Health Science Institutional review board
Ethics Committee Address
Street address City Postal code Country
Not applicable Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Recovery rate measured bu mid upper arm circumference and weight for height z-score Mid upper arm circumfernce: at the bigining, weekely and at the end. Weight for height: at the bigining, monthly and at the end.
Secondary Outcome Average weight gain Measurement of weight will be done at the begining, monthly basis and at the end.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Damot pulassa Bibiso Olola No street adress Shanto Ethiopia
Damot Pulassa Waribira Suqe No street adress Shanto Ethiopia
Damot Pulassa Ade Shanto No street adress Shanto Ethiopia
Damot pulassa Tomtome No street adress Shanto Ethiopia
Damot pulassa Lera No street adress Shanto Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Wolaita university Not applicable Sodo 1560 Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Wolaita Sodo University Not applicable Sodo 5260 Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Wolaita Zone administration Not applicable Sodo 5260 Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Debritu Nane nanedebritu@gmail.com +251911722040 Not applicable
City Postal code Country Position/Affiliation
Sodo 5260 Ethiopia PhD Candidate
Role Name Email Phone Street address
Scientific Enquiries Anne Hatloy Anne.Hatloy@uib.no +4799698766 Jussbygg II, Jekteviksbakken 31
City Postal code Country Position/Affiliation
Bergen 5020 Norway Main Supervisor
Role Name Email Phone Street address
Public Enquiries Bernt Lindtjorn bernt.lindtjorn@cih.uib.no +4795056812 Hordland 5020
City Postal code Country Position/Affiliation
Bergen 7800 Norway Co supervisor
Role Name Email Phone Street address
Public Enquiries Elazar Balla elazar.balla@kbh.uu.se +251913548828 Not applicable
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Co supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
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
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 12/09/2018 Typing error Treating moderate acute malnutrition: Effect of local ingredient based supplementary food in treating Moderate Acute Malnutrition among children aged 24 to 59 months in Southern Ethiopia: A randomized controlled trial. Treating moderate acute malnutrition: Effect of local ingredient based supplementary food in treating Moderate Acute Malnutrition among children aged 6 to 59 months in Southern Ethiopia: A randomized controlled trial.
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Recruitment status 12/09/2018 I am just working on recruitment process.. I didn't start of measuring the outcome. Closed to recruitment,follow-up continuing Recruiting
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 12/09/2018 Previously mentioned date is starting date of screening and recruitment process. It is not the starting date of intervention. 06 Aug 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 13/09/2018 This date is the date I started to screening of children's for recruitment process. 21 Aug 2018
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Anticipated date of last follow up 13/09/2018 This date is anticipated date of last follow up. 02 Nov 2018 22 Nov 2018