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.: PACTR202007493610166 Date of Approval: 02/07/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of high dietary salt on blood pressure and inflammatory cytokines in people living with HIV and HIV negative individuals with and without hypertension
Official scientific title HIV, Immune activation and salt sensitive hypertension
Brief summary describing the background and objectives of the trial High dietary salt is associated with immune activation, elevated levels of inflammatory cytokines and hypertension in murine models. Hypertension is independently associated with inflammation in both murine studies and studies in humans. In people living with HIV, these interactions are not well established. The aim of this study is to determine the effect of excess dietary salt on immune cell activation, pro- and anti-inflammatory cytokines and blood pressure between individuals with and without hypertension among people living with HIV and HIV negative persons.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) HISH
Disease(s) or condition(s) being studied Cardiology,Circulatory System,Infections and Infestations,Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied HIV/AIDS
Purpose of the trial Nutrition and Immune system
Anticipated trial start date 03/12/2018
Actual trial start date 02/01/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date 31/12/2019
Anticipated target sample size (number of participants) 84
Actual target sample size (number of participants) 85
Recruitment status Completed
Publication URL https://bmcresnotes.biomedcentral.com/articles/10.1186/s13104-019-4470-2
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
Crossover: all participants receive all interventions in different sequence during study Randomised Permuted block randomization 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
Control Group Low and high dietary salt Low salt was 4 grams per day for a week and high salt was 9 grams per day for a week. The same individuals underwent both phases to serve as their own control 3 weeks. The first week was the salt deprivation week where participants were instructed not to add salt to their food or eat salt processed foods containing salt. The second week was the low salt phase followed by the third week, the high salt phase. 21 Active-Treatment of Control Group
Experimental Group Low salt and high salt Low salt was 4 grams (NaCl) and High salt was 9 grams 3 weeks The first week was the salt deprivation week where participants were instructed not to add salt in their food or eat processed foods containing salt. The second week was the low salt intervention phase followed by the third week, the high salt phase. 21
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults (aged 18 and above) who will be required to verbally consent and sign a consent form HIV positive or HIV Normotensive individuals or hypertensive If HIV, on antiretroviral therapy ART treated hypertensive individuals Existence of co-morbidities such as diabetes mellitus and cancer Existing and recent past opportunistic infections, syphilis, hepatitis C and B virus infection and tuberculosis infection; Sick patients (clients seeking healthcare due to an illness rather than routine ART clinic reviews) Those with recent and current alcohol consumption and smoking status Adult: 19 Year-44 Year,Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 60 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 27/11/2018 The University of Zambia Health Sciences Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
John Mbita Road Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Elevated levels of pro-inflammatory cytokines At the end of the low- and high-salt phases
Secondary Outcome elevated blood pressure At the end of the low- and high-salt phases
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Livingstone Central Hospital Akapelwa street Livingstone 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Zambia Vanderbilt Partnership Training for metabolic nutrition research under the Fogarty International Center of the National Institutes of Health 2525 West End Ave Nashville 37203 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor UNZA Vanderbilt Partnership Training 2525 West End Ave, Suite 750 Nashville 37203 United States of America University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sepiso Masenga smasenga@mu.ac.zm +260977674774 Akapelwa street
City Postal code Country Position/Affiliation
Livingstone 10101 Zambia Lecturer and Postdoc Fellow
Role Name Email Phone Street address
Scientific Enquiries Sody Munsaka s.munsaka@unza.zm +260977925304 John Mbita Road
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Lecturer at the University of Zambia
Role Name Email Phone Street address
Public Enquiries Benson Hamooya benmalambo@gmail.com +260977645098 Akapelwa street
City Postal code Country Position/Affiliation
Livingstone 10101 Zambia Lecturer at Mulungushi University and doctoral student at University of Zambia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data, summary results, codes, statistical plan and informed consent will be made available immediately after publication of results. Informed Consent Form,Statistical Analysis Plan 1 year Data will be available to anyone who wishes to view
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