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.: PACTR202011602578460 Date of Approval: 09/11/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Impact of supplementation with folic acid on blood pressure in patient with essential hypertension
Official scientific title Impact of supplementation with folic acid on blood pressure in patient with essential hypertension
Brief summary describing the background and objectives of the trial Hypertension is a common global health problem in many countries including Sudan. In the year 2000, more than 25% of the world's population was estimated to have hypertension. This percentage is expected to increase to around 30% by the year 2025. In 2010, the global prevalence of hypertension among adults aged ≥ 20 years was estimated to be 31.1%. In addition to that, the proportion of worldwide morbid complications due to hypertension has significantly increased from approximately 4.5 % in 2000 to 7 % in 2010 which makes hypertension the most important cause of morbidity and mortality globally. In Sudan, the prevalence of hypertension was increased from > 20% in the year 2000 to 35 - < 40 % in the year 2010. In the urban communities of Sudan, the prevalence of hypertension has increased from 7.5% in 1990 to 18.2% in 2002. The Seventh Report of the Joint National Committee on Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) has defined hypertension was as a systolic BP >140 mm Hg, a diastolic BP > 90 mm Hg. This study aims to evaluate the impact of folic acid plus antihypertensive medications compared with antihypertensive medications alone on lowering blood pressure in patients with primary hypertension.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 16/07/2020
Actual trial start date 16/06/2020
Anticipated date of last follow up 16/09/2020
Actual Last follow-up date 30/12/2020
Anticipated target sample size (number of participants) 128
Actual target sample size (number of participants) 128
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Non-randomised Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group folic acid therapy folic acid 15 mg orally once a day three months • Group A will be administered folic acid 15 mg orally once a day for three months and antihypertensive medications indefinitely (Amlodipine, Lisinopril, Losartan, Atenolol, hydrochlorothiazide). 64
Control Group hypertension treatment three months Group B will be administered only antihypertensive medications indefinitely (Amlodipine, Lisinopril, Losartan, Atenolol, hydrochlorothiazide 64 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Patient diagnosed with essential hypertension. 2. Male or female >18-year-old. 3. Females of child-bearing potential must be non-pregnant and not lactating and using adequate birth control such as oral contraceptives. 4. Provide written informed consent. 5. Have the ability to understand the requirements of the study and to comply with the study protocol and dosing regimen. 6. Agreement to not take any other drugs that may affect blood pressure or folic acid supplements a week before and during the study period. 1. Patient suffer from other serious disease (coronary heart disease, stroke, peripheral vascular disease, kidney disease, psoriasis, neoplastic disease, hepatocellular damage, neurological diseases, inflammatory diseases or hypertensive complications. 2. Had a major operation in last 6 months. 3. Have history of alcohol or drug abuse. 4. Patients take other drugs that may affect blood pressure, lipid profile or folic acid concentrations during the study period. 5. Are considered by the investigator to be unsuitable candidate for this study. 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 80 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 15/05/2019 Research Board at the Faculty of Medicine at the University of Gadarif
Ethics Committee Address
Street address City Postal code Country
Faculty of Medicine at the University of Gadarif, Sudan Gadarif 11111 Sudan
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome mean difference in blood pressure base line, week 2, week 4, week,6, week 8, week 10, week 12
Secondary Outcome mean difference in serum folate, homocysteine, HDL-cholesterol, LDL-cholesterol, triglyceride and total cholesterol level baseline and week 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Gadarif hospital Gadarif general hospital, Gadarif Gadarif Sudan
FUNDING SOURCES
Name of source Street address City Postal code Country
Mustafa Saleh Saeed Horia street Khartoum Sudan
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor University of Gezira University of Gezira, hospital streat Wad Madani Sudan University
COLLABORATORS
Name Street address City Postal code Country
Saeed M Omar Faculty of Medicine, Gadarif University, Gadarif, Sudan. Gadarif Sudan
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mustafa Saeed musaleh16@yahoo.com 00249908002295 Alhila Algadida, Khartoum, Sudan
City Postal code Country Position/Affiliation
Khartoum 11111 Sudan Lecturer
Role Name Email Phone Street address
Scientific Enquiries Ishaq Adam ishagadam@hotmail.com 00966537644287 Qassim University, Buraidah, KSA
City Postal code Country Position/Affiliation
Buraidah Saudi Arabia Professor
Role Name Email Phone Street address
Public Enquiries Saeed Omar drsaeedomar@yahoo.com 00249912950211 Faculty of Medicine, Gadarif University, Gadarif, Sudan.
City Postal code Country Position/Affiliation
Gadarif Sudan lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after deidentification Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Beginning 3 months and ending 12 months following research publication Data will be shared with anyone who wishes to access the it for any purpose. Data will be available indefinitely at (Link to be included)
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