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.: PACTR201710002698231 Date of Registration: 17/10/2017
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Selenium biofortification intervention in central Kenya highlands
Official scientific title Selenium biofortification intervention in central Kenya highlands: impact of selenium biofortification on selenium intake adequacy for women and under-5 children
Brief summary describing the background and objectives of the trial Selenium (Se)is an essential micro-nutrient for humans and its supply in food system is highly variable. in Sub-Saharan Africa (SSA), Se intake levels are often very low in rural populations where fish intake from natural sources is limited, especially in the highlands. The mean estimated risk of Se deficiency in Kenya is 37%. In 2015, Se status assessment was conducted in central Kenya highlands that identified high risk Se deficiency regions via analysis of hair, local foods, and soil samples. In 2016, agronomic biofortification trials were conducted in the most Se deficient regions that identified Se fertilizer application dosage that can substantially increase Se concentration in local staple foods. The goal of the current study is to assess the impact of Se biofortification intervention on individual Se intake adequacy among women within reproductive age and under-5 years old children. Specifically, the study aim at agronomically biofortifying maize crops with 20g Se per hectare dose of Se fertilizer through foliar application, then analyze Se concentration in maize grains for both treatment and control groups, and finally assess the Se dietary intake of the target population against the Se Estimated Average Requirements (EARs). The most common practice to enhance Se levels in crops is through inorganic fertilization. Food samples will be collected from both treatment and control groups at harvest and shipped to Belgium for analysis at the Laboratory of Analytical Chemistry and Applied Ecochemistry, at Ghent University. Adapting the fortification strategy to the local properties of an agro-ecosystem is the way forward, as agronomic biofortification which employ the use of fertilizers containing the mineral elements lacking in human diets.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) None
Disease(s) or condition(s) being studied None,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/05/2017
Actual trial start date 01/06/2017
Anticipated date of last follow up 31/12/2017
Actual Last follow-up date 31/12/2017
Anticipated target sample size (number of participants) 180
Actual target sample size (number of participants) 160
Recruitment status Closed to recruitment,follow-up continuing
Publication URL None
Secondary Ids Issuing authority/Trial register
None PROTOCAL NO. MIRERC-016-2017
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 randomisation using a randomisation table created by a computer software program 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 Treatment group 20 g selenium fertilizer per hectare 6 months Agronomic biofortification 80
Control Group Control group No selenium added - plain water applied 6 months N/A 80 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women within the age of 19 to 39 years and children below 5 years of age remaining in the study area throughout the intervention period. Women and children with congenital or chronic abnormalities impairing feeding pattern, severely ill, with clinical conditions under feeding regimes deviating from regular diet, and non-permanent residents of the study area. 6 Month(s) 39 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 27/10/2017 Meru University Research Ethical Review Committee (MIRERC)
Ethics Committee Address
Street address City Postal code Country
P.O.Box 972 Meru 60200 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Adequacy of selenium intake After completion of the intervention period
Secondary Outcome Se content of biofortified maize grains At harvest stage - when the maize crop naturally dry due to maturity, ready for harvest
Secondary Outcome Daily selenium intake Pre- and post-interevention trial
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kanyekini Location Kiaga Sub-Location Kirinyaga County 103 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
VRIL-OUS ICP PHD Julien Dillensplein 1, P.O. Box 1A Brussels 1060 Belgium
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Meru University of Science & Technology P.O.Box 972 Meru 60200 Kenya University
Secondary Sponsor Ghent University Coupure Links 653 Gent 9000 Belgium University
COLLABORATORS
Name Street address City Postal code Country
Prof. Peter Wafula Masinde P.O.Box 972 Meru 60200 Kenya
Prof. Gijs Du Laing Coupure Links 653 Gent 9000 Belgium
Prof. Lachat Carl Coupure Links 653 Gent 9000 Belgium
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Gijs Du Laing Gijs.DuLaing@UGent.be +3292645995 Coupure Links 653
City Postal code Country Position/Affiliation
Gent 9000 Belgium Associate Professor: Applied analytical and environmental chemistry
Role Name Email Phone Street address
Public Enquiries Peter Biu Ngigi PeterBiu.Ngigi@UGent.be +254725447981 P.O.Box 972
City Postal code Country Position/Affiliation
Meru 60200 Kenya Doctoral researcher
Role Name Email Phone Street address
Scientific Enquiries Lachat Carl carl.lachat@ugent.be +3292649377 Coupure Links 653
City Postal code Country Position/Affiliation
Gent 9000 Belgium Professor: Nutrition Epidemiology
REPORTING
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Result URL Hyperlinks
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