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.: PACTR202308740458863 Date of Registration: 04/08/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effects of butternut squash seeds on iron and zinc status of children attending Early Childhood Development centres in Limpopo province, South Africa
Official scientific title Effects of butternut squash seeds on iron and zinc status of children attending Early Childhood Development centres.
Brief summary describing the background and objectives of the trial A study by Motadi et al (2015) in the Vhembe district in Limpopo province indicated that the prevalence of zinc deficiency among children, aged 3 to 5 years, was 42.6% and iron deficiency anaemia was 28%. These data reveal that two micronutrients are significant public health problems in this area of South Africa. This proposed study is a continuation from my master’s work. It aims to utilize a food-based approach to address micronutrient deficiencies observed by promoting neglected or underutilized crops such as Cucurbita Moschata seeds. In South Africa, Cucurbita Moschata is a vegetable grown for its leaves, flesh and flowers. At present the seeds are discarded mainly as a waste (Lewu and Mavengahama, 2010; Dweba and Mearns, 2011) while consuming leaves, flesh and flowers. Yet this practice may be an inadvertent waste of a precious nutritional source of essential nutrients. This target group for this study is selected as children under five years constitute the most vulnerable group of a community. Their nutritional status is a sensitive indicator of community health and nutrition. Furthermore, correcting deficiency of micronutrients can help reduce child mortality. The primary aim of this study is to test the efficacy of consumption of Cucurbita moschata (Butternut) seeds in improving zinc and iron status in preschool children in the Vhembe district, Limpopo province of South Africa, and the secondary aim is to describe the nutritional, zinc and iron status of the children.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 03/05/2021
Actual trial start date 01/06/2021
Anticipated date of last follow up 30/11/2021
Actual Last follow-up date 14/12/2021
Anticipated target sample size (number of participants) 273
Actual target sample size (number of participants) 236
Recruitment status Completed
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group butternut squash seeds Children in the butternut seeds group received 100 g of seeds per day, twice a week, for 6 months. 6 months Butternut squash was purchased from local farmers in the Musina municipality and prepared as butternut seed paste in the food service laboratory of the Division of Human Nutrition, Stellenbosch University for sensory evaluation. Seeds were removed from their cavity using a metal spoon and rinsed with water to remove any residue. The cleaned seeds were roasted in an oven for 135ºC for 20 minutes, and ground into a powder using a portable local grinding mill. The blender with the deionized water did not add iron or zinc in the grinding of the seeds. Recipes were evaluated for sensory satisfaction and six recipes were selected 151
Control Group butternut flesh The flesh group children, 100 g of butternut flesh per day, twice a week, for 6 months. 6 months butternut flesh cooked with Margerine and sugar. 85 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children who are 3-5 years old (parents consented) and present on the day of data collection were included in the study. Children who are free from infections (such as malaria, and tuberculosis). Not taking any medication (such as antacids, famotidine and ranitidine, omeprazole, pantoprazole, proton pump inhibitors and calcium supplements) were included in this study because medication alter the serum concentration and level. Exclusion criteria were children with (i) physical disabilities that hindered taking anthropometric measurements. (ii) malaria and tuberculosis disease. (iii) taking medication such as antacids, famotidine and ranitidine, omeprazole, pantoprazole, proton pump inhibitors and calcium supplements (these medications alter serum zinc concentration). (iv) being severely underweight to the extent of hospitalization. Preschool Child: 2 Year-5 Year 3 Year(s) 5 Year(s) Both
Children who are 3-5 years old (parents consented) and present on the day of data collection were included in the study. Children who are free from infections (such as malaria, and tuberculosis) and taking any medication (such as antacids, famotidine and ranitidine, omeprazole, pantoprazole, proton pump inhibitors and calcium supplements) were included in this study because medication alter the serum concentration and level. Exclusion criteria were children with (i) physical disabilities that hindered taking anthropometric measurements; (ii) malaria and tuberculosis disease; (iii) taking medication such as antacids, famotidine and ranitidine, omeprazole, pantoprazole, proton pump inhibitors and calcium supplements (these medications alter serum zinc concentration); or (iv) being severely underweight to the extent of hospitalization. Preschool Child: 2 Year-5 Year 3 Year(s) 5 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 08/02/2021 Health Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Stellenbosch University Cape Town 8000 South Africa
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 13/03/2019 Limpopo Provincial Department of Education
Ethics Committee Address
Street address City Postal code Country
Biccard and 24 Excelsior Polokwane 0700 South Africa
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 24/04/2019 Vhembe District Department of Education
Ethics Committee Address
Street address City Postal code Country
Old parliament Sibasa 0970 South Africa
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 27/05/2019 Soutpansberg North Circuit
Ethics Committee Address
Street address City Postal code Country
Dzanani Musina 0955 South Africa
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 17/05/2019 NIANI EAST CIRCUIT
Ethics Committee Address
Street address City Postal code Country
Mutale Sibasa 0956 South Africa
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 14/05/2019 Tshilamba Circuit
Ethics Committee Address
Street address City Postal code Country
Mutale Sibasa 0956 South Africa
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 24/06/2019 Niani West Circuit
Ethics Committee Address
Street address City Postal code Country
Niani Musina 0900 South Africa
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 02/04/2019 Department of Health
Ethics Committee Address
Street address City Postal code Country
18 college street Polokwane 0700 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The incorporation of butternut seeds significantly improved the iron and zinc status of these young children. after 6 months
Secondary Outcome The butternut seeds paste in their research improved underweight and wasting. Eating patterns of the children improved because of the nutrition education. 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Madimo preschool Musina Municipality Musina 0900 South Africa
Bale preschool Musina municipality Musina 0900 South Africa
Lwathudwa community creche Musina Municipality Musina 0900 South Africa
Mbodi community creche Musina Municipality Musina 0900 South Africa
Mukovhawabale community creche Musina Municipaplity Musina 0900 South Africa
Sagole community creche Musina Municipality Musina 0900 South Africa
Mafukani community creche Musina Municipality Musina 0900 South Africa
Tshaanda Community Creche Musina Municipality Musina 0900 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Venda Mphephu Road Thohoyandou 0950 South Africa
National Research Foundation South Gate CSIR Complex Pretoria 0001 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor NRF South Gate CSIR Complex Pretoria 0001 South Africa Funding Agency
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Selekane Motadi selekane.motadi@univen.ac.za +27159628683 Mphephu road
City Postal code Country Position/Affiliation
Thohoyandou 0950 South Africa University of Venda
Role Name Email Phone Street address
Scientific Enquiries Xikombiso Mbhenyane xgm@sun.ac.za +27219332991 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Stellenbosch University
Role Name Email Phone Street address
Scientific Enquiries Jeanne Freeland Graves jfg@mail.utexas.edu +15126193102 103 W 24TH ST
City Postal code Country Position/Affiliation
Austin TX 78712 United States of America University of Texas
Role Name Email Phone Street address
Public Enquiries Kwazi Zuma mkzuma@sun.ac.za +27219389135 Francie van Zijl Drive
City Postal code Country Position/Affiliation
Cape Town 8000 South Africa Stellenbosch University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes No individual participant data will be shared. Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in the effects of butternut seeds on iron and zinc status of children upon request. Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
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