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.: PACTR202102852000433 Date of Approval: 09/02/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Acute salt sensitivity of blood pressure
Official scientific title HIV INTEGRATED PERSONALIZED CARE APPROACH TO THE PREVENTION, DIAGNOSIS AND CONTROL OF SALT-SENSITIVE HYPERTENSION: THE HIPO CAP DICTSH STUDY
Brief summary describing the background and objectives of the trial Dietary salt raises blood pressure in certain individuals immediately after ingestion (acute salt sensitivity; ASS) while not affecting others. It is hypothesized that ASS is a risk factor for hypertension. However, no thresholds or diagnostic guideline is available for ASS. This study is the first aim to the main study (HIPO CAP DITSH Study) aimed at determining the threshold or blood pressure cut-offs for ASS upon ingesting dietary salt.
Type of trial CCT
Acronym (If the trial has an acronym then please provide) AcuteSS
Disease(s) or condition(s) being studied Cardiology,Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/12/2020
Actual trial start date 01/12/2020
Anticipated date of last follow up 28/02/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
Actual target sample size (number of participants) 131
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised 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 Salt ingestion 2 tablets of Sodium chloride (394 mg sodium) ingested at once 120 minutes Participants are given water and blood pressure is measured in 10 minute interval for 30 minutes immediately followed by 2 grams of sodium chloride ingested and BP measured for 120 minutes in 10 minute intervals. 66
Control Group Salt ingestion 2 tablets of sodium chloride (394 mg each) ingested at once 120 minutes Participants are given water and blood pressure is measured for 30 minutes in 10 minutes intervals. This is followed by additional 120 minutes of blood pressure measured in 1o minutes interval after the participant ingests the salt 66 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Adults aged 18 years and above Hypertensive (should be off antihypertensive medication at least 2 weeks prior to the study) and normotensive diabetes patients ill participants Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 79 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 26/06/2020 University of Zambia Biomedical research Ethics committee
Ethics Committee Address
Street address City Postal code Country
John Mbita road, ridgeway campus Lusaka 10101 Zambia
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 05/08/2020 National Health Research Ethics Board
Ethics Committee Address
Street address City Postal code Country
John Mbita Road, University Teaching Hospital Lusaka 10101 Zambia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Systolic blood pressure change of equal to or more than 20 mmHg Every 10 minutes for 120 minutes
Secondary Outcome Diastolic blood pressure change of equal to or more than 10 mmHg 10 minute interval for 120 minutes
Primary Outcome Blood pressure change of equal to or more than 10 mmHg 10 minute interval for 120 minutes
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Livingstone Central Hospital Akapelwa street, Livingstone Town Livingstone 10101 Zambia
FUNDING SOURCES
Name of source Street address City Postal code Country
Fogarty International Center of the National Institutes of Health 2525 West end avenue Nashville 37203 United States of America
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Vanderbilt University Medical Cemter 2525 west end avenue Nashville 37203 United States of America University
COLLABORATORS
Name Street address City Postal code Country
University of Zambia John Mbita Road, Ridgeway campus Lusaka 10101 Zambia
Mulungushi University School of Medicine and Health Sciences Akapelwa street, Livingstone campus Livingstone 10101 Zambia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sepiso Masenga sepisomasenga@gmail.com +260966674774 John Mbita Road, Ridgeway campus, University of Zambia
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Research Fellow Postdoc
Role Name Email Phone Street address
Public Enquiries Selestine Nzala shnzala@unza.zm +260979176779 John Mbita Road, Ridgeway Campus, University OF Zambia
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Department of medical education development University of Zambia
Role Name Email Phone Street address
Scientific Enquiries Sody Munsaka s.munsaka@unza.zm +260977925304 John Mbita road, Ridgeway campus
City Postal code Country Position/Affiliation
Lusaka 10101 Zambia Acting dean School of Health Sciences University of Zambia
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individula data collected during the trial, afterdeidentification will be available, including statistical analysis plan, consent forms, codebook. Analytic Code,Informed Consent Form,Study Protocol Immediately following publication Anyone who wishes to access the data may request from the principal investigator
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