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.: PACTR201807135085505 Date of Registration: 25/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Saving Brains from Malnutrition
Official scientific title SAVING BRAINS FROM MALNUTRITION: IMPLEMENTATION OF EVIDENCE-BASED NUTRITIONAL SUPPLEMENTATION AND PSYCHOSOCIAL STIMULATION PROGRAMME FOR PREGNANT AND LACTATING WOMEN AND THEIR INFANTS POST WEANING, TO IMPROVE COGNITION AND BEHAVIOURAL REGULATION TO DELIVER BETTER SOCIAL AND ECONOMIC PROSPECTS LATER IN LIFE
Brief summary describing the background and objectives of the trial This is an acceptability of standard and enhanced Small Quantity Lipid-based Nutrient supplements (SQ LNS/eSQ LNS) in addition to 1g Omega 3 Fatty Acids by Ghanaian women and their infants. Objectives 1. To assess the acceptability and adherence to nutrient supplementation with micronutrient supplements for 6 weeks among n=120 pregnant and lactating women and n=60 month old offspring post weaning. 2. assess the feasibility of measuring plasma and red cell membrane concentrations of polyunsaturated fatty acids among pregnant and lactating mothers and6 month old infants post weaning. 3. To assess the feasibility of using computerised eye tracking to asses neurocognition in 40 children, aged 18 months 4. To modify the psychosocial stimulation programme for the Ghanaian setting and train staff in its application
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Saving Brains
Disease(s) or condition(s) being studied Malnutrition
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/08/2018
Actual trial start date
Anticipated date of last follow up 31/12/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 180
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 Dynamic (adaptive) random allocation such as minimization Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group nutritional supplement and fish oils 6 weeks Subject groups will be randomized to nutritional supplements and fish oils for 6 six week 90
Control Group nuritional supplemet and fish oils 6 weeks Subject groups will be randomized to nutritional supplements and fish oils for 6 six week 90 Dose Comparison
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
infant between 6 -18 months, mothers, lactating mothers infants less than 6 months, an unwell pregnant woman, persons allergic to peanut Adult: 18 Year(s)-44 Year(s),Infant: 13 Month(s)-24 Month(s) 6 Month(s) 44 Year(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 17/04/2018 Ghana Health Service Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Accra Accra 0000 Ghana
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Taste evaluation start of pilot
Secondary Outcome Taste Evaluation Start of pilot
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Suntreso Government Hospital Kumasi Kumasi Ghana
Tafo Government Hospital Kumasi Kumasi Ghana
Kumasi South Government Hospital Kumasi Kumasi Ghana
FUNDING SOURCES
Name of source Street address City Postal code Country
Nutriset Malaunay Malaunay France
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nutriset Malaunay Malaunay France Commercial Sector/Industry
COLLABORATORS
Name Street address City Postal code Country
Prof. Terrence Forrester University of West Indies Mona Jamaica
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Jacob Plange Rhule jprhule@gmail.com +233244458455 Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Associate Professor Kwame Nkrumah University of Science Technology
Role Name Email Phone Street address
Scientific Enquiries Terrence Forrester terrence.forrester@uwimona.edu.jm +0000000000000 Mona
City Postal code Country Position/Affiliation
Mona Jamaica Professor University of West Indies
Role Name Email Phone Street address
Public Enquiries Kezia Gladys Amaning Adjei kezmantey@gmail.com +233269620850 Kumasi
City Postal code Country Position/Affiliation
Kumasi Ghana Research Coordinator Kwame Nkrumah University of Science and Technology Kumasi Ghana
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