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.: PACTR201812690668771 Date of Approval: 12/12/2018
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Evaluating the the roles of nutrition specific interventions on linear growth among children in food in secured households, Ethiopia
Official scientific title The roles of selected micro-nutrient supplementation and key complementary feeding message on linear growth of children 6-36 months, Ethiopia. A cluster randomised trial.
Brief summary describing the background and objectives of the trial To evaluate the roles of different nutrition sensitive interventions packages on the health and linear growth among children 6-36 months age in poor households of Amhara and Oromia region, Ethiopia. It is a cluster randomized control trial aimed at evaluating the effects of different packages of nutrition sensitive intervention; adapting from Lancet Maternal and Child Nutrition Series 2013 list considering windows of opportunity of the first 1000 days of life (from conception to two years of age) to provide robust evidence as to which bundle(s) of intervention can have significant effect on health and linear growth of children in food in secured households of Ethiopia. Generally this study is aimed to identify the best nutrition intervention packages in specific community settings that positively affect the health and linear growth of the children from 6-36 months of age as compared to the control arm.
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 Enhanced micro nutrient supplementation and key child feeding messages to the child care taker
Anticipated trial start date 27/08/2018
Actual trial start date
Anticipated date of last follow up 30/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 511
Actual target sample size (number of participants)
Recruitment status Closed to recruitment,follow-up continuing
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 Permuted block randomization Numbered containers Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Treatment arm one 10 mg of Zinc tablets ; 50,000 IU Vitamin A ; proper utilization of Iodized salt and posting 10 key nutrition messages ,food and cash transfer , involve in livelihood and saving activities and get public health service delivered from the government side. one year 10 mg of Zinc tablets for ten days with every episode of diarrhea; 50,000 IU Vitamin A supplementation every six months; proper utilization of Iodized salt with complementary food and posting 10 key nutrition messages at home and reinforcing the nutritional messages during home visit every month in addition to food and cash transfer that will be given for food insecured households from donors , involve in livelihood and saving activities through village economic and social associations(VESA), male involvement in nutrition activities and nutrition education is among the activities in addition to the public health service delivered from the government side. 170
Control Group Control group As they are food in secured households they will get food and cash transfer from the government in addition to the usual public health service They will get through out the year As they are food in secured households they will get food and cash transfer from the government in addition to the usual public health service 170 Historical
Experimental Group Treatment arm 2 Receive food and cash transfer from a nongovernmental organization(SPIR-DFSA) , involve in animal rearing, poultry production and saving activities through village economic and social associations(VESA), involve in community dialogue to improve male involvement in nutrition activities and they get public health service delivered from the government side. One year These are food in secured households who receive food and cash transfer from a nongovernmental organization(SPIR-DFSA) , involve in animal rearing, poultry production and saving activities through village economic and social associations(VESA), involve in community dialogue to improve male involvement in nutrition activities and they get public health service delivered from the government side. 170
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
• All children 6-24 months age with their mothers • Living in food in secured households • Targeted for productive safety net program • Are permanent residents of the study area, living at least for 6 months • All children residing in areas where nutrition sensitive interventions currently implemented either by government or non-government agencies in the selected cluster • Households which is too hard to reach • Children with known chronic or acute illness and bedridden during the study period. Infant: 1 Month-23 Month 6 Month(s) 24 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 02/05/2018 Dr. Ayalew Astatike
Ethics Committee Address
Street address City Postal code Country
Hawassa Hawassa 1560 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Stunting At baseline and after one year of intervention
Secondary Outcome Health condition of the index child At baseline and after one year intervention
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
productive safety net targeted ares of Amhara and Oromia regions in Ethiopia Street address is not applicable in the area rather names of district Hawassa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
USAID food for peace through World vision Ethiopian Adiss Ababa Adiss Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Hawassa University Hawassa Hawassa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Professor Barbara stocker --- Oklahoma United States of America
Dr.Kaleab Baye -- Adiss Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Zelalem Tafese wudasiez@gmail.com +251911479506 Hawassa
City Postal code Country Position/Affiliation
Hawassa Ethiopia PhD candidate
Role Name Email Phone Street address
Scientific Enquiries Stoeker Barbara barbara.stoecker@okstate.edu 0027229045 Oklahoma
City Postal code Country Position/Affiliation
Oklahoma United States of America Professor
Role Name Email Phone Street address
Public Enquiries Kaleab Baye kaleabbaye@gmail.com +251911890489 Adiss Ababa
City Postal code Country Position/Affiliation
Adiss Ababa Ethiopia Professor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
No
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