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.: PACTR201908774181973 Date of Approval: 26/08/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of vitamin D on renin angiotensin system in heart failure patients
Official scientific title Effect of vitamin D on renin angiotensin system in heart failure patients with reduced ejection fraction
Brief summary describing the background and objectives of the trial Heart failure with reduced ejection fraction (HF ref) is a public health problem. Most medications acting on renin angiotensin system (RAS) has been proved to improve prognosis. In some trials vitamin D showed a posiitive effect on renin angiotensin system and in others it showed a favorable effect on left ventricular remodeling. This trial aims to assess the effect of a vitamin D supplementation on the concentration of active renin in HF ref patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Circulatory System
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2019
Actual trial start date 01/09/2019
Anticipated date of last follow up 31/12/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 80
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider,Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group vitamin D 200 000 UI per os , two intakes at 1 mont interval two intakes at 1 mont interval vitamin D oral intake 40
Control Group control placebo 2 administrations at 1 month interval placebo 40 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
adults > 18 years heart failure with left ventricular ejection fraction =< 40% either ischaemic or non ischaemic origin clinically stable (NYHA 1 or 2 , no signs of peripheric poor perfusion and systolic blood pressure >= 90 mmhg) blood concentration of vitamin D =< 50 nmol/l non inclusion criteria heart faiture decompensation and worsening clinical status, cardiogenic schock renal insufficiency with cockroft formula creatinin claerance =< 15 ml/mn baseline calcemia > 2.6 mmol/l baseline blood concentration of vitamin D > 50nmol/l exclusion criteria calcemia > 2.6 mmol/l before the second administration of vitamin D blood concentration of vitamin D > 50nmol/l before the second administration of vitamin D 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 19 Year(s) 99 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
No 14/05/2019 comite de protection de personnes nord
Ethics Committee Address
Street address City Postal code Country
instut pasteur de tunis 13, place Pasteur tunis 1002 Tunisia
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 29/05/2019 the institutional review board North
Ethics Committee Address
Street address City Postal code Country
Parsteur institute of Tunisia, 13 pasteur square B.P 74 tunis 1002 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome lowering of active renin plasma concentration 15 days after the second admnistration of vitamin D
Secondary Outcome lowering of plasma level of brain natriuretic peptide (BNP) 15 days after the second administration of vitamin D
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
functional cardiac explorations and cardioreanimation service cardiology department Rabta hospital djebel lakhdhar street 1007 bab saadoun tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
rabta hospital rue djebel lakhdhar bab saadoun tunis 1007 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor rabta hospital rue djebel lakhdhar bab saadoun tunis 1007 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
feki moncef biochaemistry service rabta hospital 15 rue djebel lakhdhar bab saadoun tunis 1007 Tunisia
sameh haj taieb biochaemistry service rabta hospital 15 rue djebel lakhdhar bab saadoun tunis 1007 Tunisia
mourali mohamed sami cardiac functional explorations and cardioreanimation service rabta hospital 15 rue djebel lakhdhar bab saadoun tunis 1007 Tunisia
guerfali mariem pharmacy service rabta hospital 15 rue djebel lakhdhar bab saadoun tunis 1007 Tunisia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator fathia mghaieth zghal mghaieth zghal fathia.zghal@fmt.utm.tn 0021698648676 cardiology department rabta hospital rue djebel lakhdhar bab saadoun
City Postal code Country Position/Affiliation
tunis 1007 Tunisia MCA cardiology faculty of mecicine of tunis university tunis el manar cardiology department rabta hospital
Role Name Email Phone Street address
Public Enquiries fathia mghaieth zghal fathia.zghal@fmt.utm.tn 0021698648676 cardiology department, rue djebel lakhdhar bab saadoun
City Postal code Country Position/Affiliation
tunis 1007 Tunisia MCA cardiology faculty of mecicine of tunis university tunis el manar cardiology department rabta hospital
Role Name Email Phone Street address
Scientific Enquiries fathia mghaieth zghal fathia.zghal@fmt.utm.tn 0021698648676 cardiology department, rue djebel lakhdhar, bab saadoun ,
City Postal code Country Position/Affiliation
tunis Tunisia MCA cardiology faculty of mecicine of tunis university tunis el manar cardiology department rabta hospital
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes individuatl plan data would be anonymized by informatic secured system the patient will share a same number regristration in cardiology and biochemistry departments the clincal, echocardiographic and biological data of each patient will be shared on PACTR site Analytic Code,Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol protocol, statistical analysis and consent form will before october 31th 2019 cliinical study report before december 31th 2019(recruitement period) primary results will be available by march 2020 final results will beavailable by june 2020 open data can be requested by the patient aonymized data can be requested by the funder and editorial obards of publication journals or other requests foe metanalyses studies the research and ethical boeard of the Faculty of medicine ot Tunis with Rabta hospital ethical committees will review these requests i
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