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.: PACTR202004842786087 Date of Approval: 28/04/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of Spirulina Corn Soy Blend on Protein Energy Malnourished and Iron Deficient children aged 6-23 months in Ndhiwa Sub-County-Kenya
Official scientific title An intervention involving 240 malnourished children randomly assigned to either SCSB,CSB and placebo groups through lottery.
Brief summary describing the background and objectives of the trial PEM and IDA are public health problems affecting children despite of many interventions. In Kenya the standard intervention for malnutrition have been done using CSB which is limited in meeting the calorie and micronutrient needs of children. The production of CSB is not feasible at the household level to support local production and the micronutrient premix is used to fortify CSB is not accessible and affordable moreover information on the impact of cereal blends used to manage PEM and the use of spirulina to fortify CSB as well as the use of SCSB to ma manage malnutrition in Kenya is scarce. To address these gaps, this RCT's main objective was to establish impact of SCSB on Retinol Binding Protein (RBP) status, Hematocrit (Hct) status, Weight-for-height Z-score and Weight-for-Age Z score of malnourished children in Ndhiwa Sub-County
Type of trial RCT
Acronym (If the trial has an acronym then please provide) SCSB PEM IDA RBP Hct
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 12/03/2012
Actual trial start date 08/10/2012
Anticipated date of last follow up 12/08/2013
Actual Last follow-up date 12/08/2014
Anticipated target sample size (number of participants) 276
Actual target sample size (number of participants) 240
Recruitment status Completed
Publication URL Trial has not yet been published nor registered and so there is no 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 Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group SCSB 200ml 6 months Dry take-home of 1.7kg SCSB flour ration distributed biweekly to caregivers who were instructed to prepare porridge using flour water ratio of 1:4, to produce 600ml-700ml volume of porridge and feed the index child on 200ml porridge three times a day at 8:00am, 2:00pm and 5:00pm 80
Experimental Group CSB 200ml porridge three times a day 6 months Dry take-home of 1.7kg CSB flour rations distributed biweekly to caregivers who were instructed to prepare porridge using flour water ratio of 1:4, to produce 600ml-700ml volume of porridge and feed the index child on 200ml porridge three times a day 80
Control Group Placebo 200ml porridge three times a day 6 months Dry take-home of 1.7kg placebo flour ration distributed biweekly to caregivers who were instructed to prepare porridge using flour water ratio of 1:4, to produce 600ml-700ml volume of porridge and feed the index child on 200ml porridge three times a day 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
MUAC 115mm to 125mm WHZ score >-3 to <-2 WAZ score >-3 to <-2 Severe acute malnutrition HAZ <-3 Zscores Bilateral edema Pre-exsisting conditions such as cancers, heart, kidney and liver conditions on intervention by the time of recruitment Infant: 13 Month(s)-24 Month(s) 6 Month(s) 23 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 13/08/2012 Kenyatta National Hospital University of Nairobi Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Hospital Road Nairobi 00200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Retinol Binding Protein Baseline and end of study at 6th month
Primary Outcome Hematocrit Baseline and end of study at 6th month
Primary Outcome WHZ Baseline monthly during intervention up to 6 months
Primary Outcome WAZ Baseline monthly during intervention up to 6 months
Secondary Outcome Dietary intake Baseline monthly during intervention up to 6 months
Secondary Outcome Morbidity Baseline monthly during intervention up to 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Ndhiwa SubCounty Hospital Ndhiwa Ndhiwa 001000 Kenya
Mirogi Mission Health center Mirogi Ndhiwa 001000 Kenya
Riana Health center Oria Ndhiwa 001000 Kenya
Okok Dispensary Kaumo Ndhiwa 001000 Kenya
Malela Dispensary Malela Ndhiwa 001000 Kenya
Magina dispensary Magina Ndhiwa 001000 Kenya
Nyarongi dispensary Kanyidoto Ndhiwa 001000 Kenya
Pala Ndhiwa Ndhiwa 001000 Kenya
Koduogo Ndhiwa Ndhiwa 001000 Kenya
Ndisi dispensary Mirogi Ndhiwa 001000 Kenya
okota dispensary kabwoch Ndhiwa 001000 Kenya
Got Kojowi health center Ratanga Ndhiwa 001000 Kenya
Kobodo dispensary Ndhiwa Ndhiwa 001000 Kenya
Rangenya dispensary Ratanga Ndhiwa 001000 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Dorothy Apondi Othoo JKUAT Nairobi 00200 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Dorothy Othoo JKUAT NAIROBI 00200 Kenya Individual
COLLABORATORS
Name Street address City Postal code Country
No collaborators No collaboratos No collaborators 00200 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Dorothy Othoo othoodapa@gmail.com +254722244472 JKUAT
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Lecturer
Role Name Email Phone Street address
Scientific Enquiries Sophie Ochola sochola55@gmail.com +254721449803 KU
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Supervisor
Role Name Email Phone Street address
Scientific Enquiries Elizabeth Kuria ekizabethnkuria@yahoomail.com +254721433619 KU
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Supervisor
Role Name Email Phone Street address
Public Enquiries Judith Kimiywe jokimiywe@gmail.com +254721915459 KU
City Postal code Country Position/Affiliation
Nairobi 00200 Kenya Supervisor
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No significant difference in demographic and socioeconomic as well as RBP, Hct, WHZ, WAZ, caloric and iron intakes and morbidity at baseline. Results for RBP and Hct were significantly different RR:P<0.05 for SCSB group as well as WHZ and WAZ at month 3,4,5 and 6 of intervention(RR:P<0.05) Clinical Study Report Additional documents can be availed as needed since the study including findings was successfully completed in 2016 There is control access to data. Data can be requested by the interested party formally in writing to the Principle Investigator. The intent for use of data should be declared in the request and analysis is limited to basic descriptive statistics, more details can be sought from the Principle Investigator and the Supervisors. The document can be available for sharing for a period not exceeding 24 months.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
www.semanticscholar.org Yes Children in SCSB significantly recovered from PEM by their RBP status (RR=3.07;CI 2.62-2.71;p=0.004), their WHZ-score, (at month 3(RR=2.21;CI:0.09-0.357;p=0.007), month4 (RR=2.49;CI:0.09-1.20;p=0.002), month 5 (RR=2.73;CI:0.00-0.47;p<0.001) and month 6(RR=3.1;CI:0.00-0.48; p<0.001) and by their WAZ-scores at month 3(RR=1.96;CI:0.15-0.38;p=0.002), month 4 (RR=2.17;CI:0.04-0.38;p<0.001), month 5(RR=2.36;CI:0.00-0.46;p<0.001) and month 6(RR=3.58;CI 2.91-3.88;p<=0.001). Magnitude of change in RBP status of children in EG1 was significantly higher (d=0.862;p=0.001) than those who consumed CSB and placebo. Children in SCSB had higher recovery rates (Log-rank-X2; p<0.001) than those in CSB and placebo. Children in SCSB were 3 times more likely to have normal RBP status, WHZ and WAZ than those who consumed CSB and those in placebo. 05/12/2016 05/12/2016
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks www.semanticscholar.org
Changes to trial information