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.: PACTR202307740330512 Date of Approval: 11/07/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Effect of COVI Soup on BMI, Immunological and Haematological Parameters Among People Living With HIV in Kakamega County Kenya
Official scientific title An Open Parallel Randomized Control Trial on Effect of COVI Soup on BMI, Immunological and Haematological Parameters Among People Living With HIV in Kakamega County Kenya
Brief summary describing the background and objectives of the trial Coronavirus Disease 2019 (COVID 19) has rapidly spread around the world with approximately 37.9 million People Living with HIV (PLWH) at risk of infection with Severe Acute Respiratory Syndrome Corona Virus 2 (SARS-CoV-2). The pandemic has the potential to lead to serious negative health outcomes for PLWH. Lack of effective antiretroviral treatment (ART) against SARS-CoV-2 impede the current measures to fight the disease threatening immuno-compromised individuals’ lives. Supportive therapy plays a major role for the patients to fight this pandemic. The main objective of this study is to determine the effect of Covi soup on BMI, Immunological and Hematological parameters among PLWH. Specific objectives are to determine the effect of Covi soup on; Body Mass Index (BMI); CD4+ cell count; Viral Load (VL) and Hematological parameters. This will be an Open Randomized Control Trial (RCT) conducted in Kakamega County Teaching and Referral Hospital (KCTRH) Comprehensive Care Centre (CCC) from August to November 2023. Purposive sampling will be used to select the study area and study site while systematic random sampling will be used to select the study participants. Block randomization will be used to place participants in either treatment group or control group. Approximately 48,752 are PLWH in Kakamega County. A RCT formula will be used to determine the sample size of 60 participants assuming 30 participant for treatment group and 30 for control group. Treatment group will receive standard care alongside Covi soup while the control group will exclusive receive standard care. Data will be collected using researcher administered questionnaire and laboratory report forms. Data will be keyed in Statistical Packages for Social Sciences (SPSS) and analyzed using paired t-test to determine the effect of Covi soup on BMI, CD4+ cell count, VL and Hematological parameters.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Infections and Infestations
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Physical activity and nutrition
Anticipated trial start date 01/08/2023
Actual trial start date
Anticipated date of last follow up 01/11/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 60
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 Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Covi soup alongside Standard care 1 serving of Covi soup (16.35g) ones daily Standard care will be administered according to the physician's prescription and the nutrition care plan. Covi soup and Standard care will be administered for 90 days. 16.35g of Covi soup is made from a mixture of; 3.75g butternut squash, 0.75g ginger, 0.5g garlic, 0.5g sunflower seeds, 0.5g chia seeds, 0.1 chilli pepper, 0.25g turmeric and 10g thickening agent. Standard care involves the use of anti-HIV drugs and Nutrition counselling as per the Kenya National Guidelines of Nutrition in HIV/AIDS. 30
Control Group Standard care Daily treatment according to the physician's prescription and nutrition care plan. Administered for 90 days. Standard care entails use of anti-HIV drugs and Nutrition counselling. 30 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
PLWH aged 15-65 years. PLWH on anti-HIV drugs for a maximum of five years. PLWH adhering to anti-HIV treatment for the past 3 years. PLWH with a CD4+ cell count >200cells/microliter of blood. PLWH who give informed consent. PLWH attending the Kakamega County Teaching and Referral Hospital CCC from the same household. PLWH on other medications other than ARTs. PLWH on ARVSaquinavir and Ritonavir. Pregnant and Lactating women living with HIV. PLWH with CD4+ cell count >200cells/microliter of blood who are severely ill. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 15 Year(s) 65 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 03/03/2023 Masinde Muliro University of Science and Technology Institutional Scientific and Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
P.o Box 190 Kakamega 501100 Kenya
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Body mass index an anthropometric measure that will be used to describe the nutrition status of the study participants. BMI is used to predict the HIV progression. Increased BMI is associated with cardiovascular diseases that are risk factors to COVID 19 infection. Decreased BMI is also associated with immune suppression that increases susceptibility to co infections like COVID 19. Hence, in this study seeks to determine whether Covi soup can have a positive effect on the BMI of PLWH in Kakamega county, Kenya. Baseline before allocation to the intervention and post study after administration of the intervention in 90 days
Primary Outcome CD4 cell count. These are a type of immunological cells that are greatly affected by the HIV. They are used as markers for disease progression. WHO CD4 ranges are used to define the clinical stage of HIV infection. This study seeks to establish the effect of Covi soup on the CD4 count of PLWH in Kakamega county, Kenya. Baseline - before allocation of intervention and Post study after administration of intervention in 90 days.
Primary Outcome No of Viral Load in copies per milliliter of blood. VL is used to determine disease progression and adherence to drugs. This study will determine the effect of Covi soup on the VL. At baseline before allocation to intervention and post study after administration of the intervention
Primary Outcome Hb in grams per deciliter. Decreased Hb indicates iron deficiency anemia which is a marker of disease progression. The study will determine the effect of Covi on the Hb level of PLWH in Kakamega county. Hb less than 12.0g/dl will be defined as anemic in both men and women. At baseline before allocation to intervention and post study after allocation to intervention
Primary Outcome Mean Corpuscular Volume in femtoliters. Low MCV indicates microcytic anemia due to iron deficiency, High MCV indicates macrocytic anemia due to low folate and vitamin B12. The study will determine effect of Covi soup on MCV of PLWH in Kakamega county. Baseline before allocation to intervention and post study after allocation to the intervention.
Primary Outcome Mean Corpuscular Hemoglobin in picograms. Hypochromic anemia indicates iron deficiency anemia, hyperchromic anemia means deficiency of vitamin B12 and folate. The study seeks to find out the effect of Covi soup on the MCH level of PLWH in Kakamega county. At Baseline before allocation to intervention and post study after allocation to the intervention.
Primary Outcome Mean Corpuscular Hemoglobin Concentration in percentage. Hypochromic anemia is a sign of iron deficiency anemia and hyperchromic anemia indicates hymolytic anemia. This study will investigate the effect of Covi soup on the MCHC level of PLWH in Kakamega county. At baseline before allocation to intervention and post study after allocation of the intervention.
Secondary Outcome Nutrition status. The study will investigate whether Covi soup has an effect on the nutrition status of PLWH. Good nutrition status is important to slow the disease progression in HIV by reducing the risk of getting opportunistic and co infections such as Covi soup. At Baseline and Post study.
Secondary Outcome Immune status which will be determined by CD4 cell count and VL. At Baseline and post study
Secondary Outcome Hematological status of PLWH in which the Hb, MCV, MCH and MCHC will be measured. At Baseline and post study
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Kakamega County Teaching and Referral Hospital Comprehensive Care Clinic. P.O Box 15 Kakamega 50100 Kenya
FUNDING SOURCES
Name of source Street address City Postal code Country
Masinde Muliro University of Science and Technology P.O BOX 190 Kakamega 50100 Kenya
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Masinde Muliro University of Science and Tachnology 190 Kamega 50100 Kenya University
COLLABORATORS
Name Street address City Postal code Country
Caleb Sagam P.O BOX 190 Kakamega 50100 Kenya
Jane Situma P.O BOX 190 Kakamega 50100 Kenya
Lucy Mutuli P.O BOX 190 Kakamega 50100 Kenya
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Antonette Kivelenge kivelengeantonette@gmail.com +254710136600 P.O BOX 150
City Postal code Country Position/Affiliation
TIRIKI 50309 Kenya Trainer of Nutrition and Dietetics
Role Name Email Phone Street address
Public Enquiries Antonette Kivelenge kivelengeantonette@gmail.com +254710136600 P.O BOX 150
City Postal code Country Position/Affiliation
TIRIKI 50309 Kenya Trainer of Nutrition and Dietetics
Role Name Email Phone Street address
Scientific Enquiries Antonette Kivelenge kivelengeantonette@gmail.com +254710136600 P.O BOX 150
City Postal code Country Position/Affiliation
TIRIKI 50309 Kenya Trainer of Nutrition and Dietetics
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Data obtained through this study will be provided to qualified researchers with academic interests in nutrition in HIV/AIDS. Data shared will be coded with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with requesting party. Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Data request can be submitted starting 12 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 priided following review and approval of a research proposal and statistical analysis plan (SAP) and execution of Data Dharing Agreement (DSA). For sharing request, contact kivelengeantonette@gmail.com.
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