CKDuNCT02226055
An Investigation Into the Cardiovascular Risk and Aetiology of CKDu in Sri Lanka
An observational study of CKDu and Arterial Stiffness, run by University of Edinburgh at 1 site in Sri Lanka.
Trial summary
1. We hypothesise that CKDu patients will have increased arterial stiffness and thus increased all-cause and cardiovascular mortality. The first objective of this study is to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura, and measure their arterial stiffness using the TensioMed®… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- CKDu, Arterial Stiffness, Proteinuria
- What is being tested?
- Arterial Stiffness Assessment
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 1 siteSri Lanka
- Study dates
- Sep 2014to 1 May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending clinics or admitted to hospital during Aug 2014 to Oct 2014 with CKDu (Chronic kidney disease of unknown origin). Subjects must be aged 18 to 85 with evidence of renal dysfunction and no other obvious cause noted (see inclusion/exclusion criteria above). Control groups will be sought for the measure of arterial stiffness: Sri Lankan CKD of known cause, Sri Lankan healthy volunteers. Our controls will be age, sex and blood pressure matched to the cases.
Who may be able to join
- Age 18- 85 years
- Attend CKDu clinic in Anuradhapura or Padavi-Sri Pura
- Evidence of renal dysfunction: proteinuria, raised serum creatinine
- Able to understand information given and happy to give consent
- Age 18- 85 years
- Present in Anuradhapura teaching hospital as a visitor/carer of patient in ward or at outpatient clinic at either site
Show all 12Show fewer
- Able to understand information given and happy to give consent
- Age 18- 85 years
- Attend general renal clinic in Anuradhapura or Padavi-Sri Pura
- Evidence of renal dysfunction: proteinuria, raised serum creatinine
- Known cause renal disease proven by biopsy or strong association such as diabetes mellitus or chronic, severe hypertension.
- Able to understand information given and happy to give consent
Who cannot join
- Subjects who are on dialysis
- History of diabetes
- History of major cardiac (including MI), respiratory (including asthma \& COPD) or neurological disease
- Pregnant
- History of significant hypertension (>140/90mmHg despite anti-hypertensives or >160/100mmHg untreated)
- History of glomerulonephritis or other known cause of renal disease
Show all 13Show fewer
- Age < 18 or >85 years
- Evidence of renal dysfunction: proteinuria, raised serum creatinine
- Evidence of diabetes mellitus, significant hypertension (defined above), glomerulonephritis or other known cause of renal disease.
- Age < 18 or >85 years
- CKD unknown origin
- Pregnant
- Subjects who are on dialysis
Trial locations and contacts
1 site in 1 country.
Sri Lanka1 site
Teaching Hospital Anuradhapura
Anuradhapura, North Central Province, A13
About this study
- We hypothesise that CKDu patients will have increased arterial stiffness and thus increased all-cause and cardiovascular mortality. The first objective of this study is to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura, and measure their arterial stiffness using the TensioMed® Arteriograph™ (details below). We will recruit an age, sex and blood pressure matched control group of healthy Sri Lankans (consenting visitors with patients both to clinic and as inpatients), and if possible, a second control group, similarly age, sex and blood pressure matched, who have CKD of known causes and attend general renal clinic in Anuradhapura.
- We hypothesise that detailed renal analysis will give insight into the aetiology of CKDu in the North Central Province of Sri Lanka. The second objective of the study is to recruit up to 250 CKDu patients and to characterize their disease profile using analysis serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.
Read the detailed description
Chronic kidney disease (CKD) is one of the leading causes of hospital admission, clinic attendance and mortality in some provinces of Sri Lanka. In central and southern provinces increased incidence is attributed to type-2 diabetes and hypertension; however, this is not the case in North Central Province (NCP) where CKD of unknown aetiology (CKDu) is the commonest diagnosis. A recent World Health Organisation (WHO) investigation concluded that at least 8,000 people have CKDu2.
First recognized in the early nineties, much work has been done to try to characterise the disease however results are conflicting. Most suggest male paddy farmers working in rural areas of the NCP are worst affected, presenting in their fifth decade with end stage renal failure. However, a recent WHO study revealed higher prevalence in females, although more severe renal impairment was more common in men.
Risk factors include inhabiting NCP > five years, inhabiting the 'dry zone', reduced BMI, lower socio-economic class, and exposure to agrochemicals. There has been suggestion of a genetic link although positive family history is limited to one generation, with no evidence of mendelian progression. Epidemiological studies reveal a clustered geographical distribution with areas such as Medawachchiya, Padaviya and Girandurukotte most affected. High prevalence areas encompass a well-developed irrigation system used for agricultural purposes.
Renal biopsies show tubulointerstitial disease with tubular atrophy, interstitial mononuclear cell infiltration, interstitial fibrosis but no immune-complex deposition on immunofluorescence. This supports a toxin-mediated process.
Many aetiologies have been considered including exposure to heavy metals (cadmium, arsenic) and their chelation by herbicides, fluro-aluminium complexes, agricultural pesticides, mycotoxins, and herbal medicines. Selenium deficiency and genetic susceptibility may be predisposing factors. The true aetiology is likely multifactorial.
The multi-system impact of CKDu has yet to be fully realised. Epidemiological and clinical data show that damage to large arteries contributes to the increased cardiovascular risk observed in CKD. Atherosclerosis is the most frequent cause of arterial damage but the medial calcification seen in CKD also leads to arterial stiffening. This stiffening causes elevation in systolic blood pressure, increasing left ventricular workload with the gradual development of LVH, and also a fall in diastolic blood pressure impairing coronary blood flow. Arterial calcification and stiffness are independent predictors of all-cause and cardiovascular mortality in patients with CKD. Arterial stiffness will be compared in CKDu patients, healthy Sri Lankan controls and CKD patients both in Sri Lanka and Scotland.
We will perform a prospective observational study of up to 250 patients with CKDu presenting to renal clinics in Teaching Hospital, Anuradhapura. Patient history, basic anthropometric measurements, and simple non-invasive tests (e.g. blood pressure and arterial stiffness) will be performed. Urine, serum and plasma samples will be collected for quantitative PCR, and further analysis for biomarkers of renal injury, exosomes, proteomics and any DNA-adducts. Patients will be graded using the WHO CKDu grading system. When a renal biopsy is performed, a copy of the light microscopy findings will be obtained. Comparisons of interest will be tested via paired t-tests with statistical significance taken at 5%.
- Conditions
- CKDu, Arterial Stiffness, Proteinuria, Serum Creatinine, Urinary Biomarkers, DNA Adducts
- Being tested
- Arterial Stiffness Assessment
- Keywords
- Chronic kidney disease of unknown origin, Chronic kidney disease of unknown aetiology, Sri Lanka, CKDu, Arterial stiffness, Cardiovascular risk, North Central Province
- Medical subject headings
- Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Stiffness AssessmentDevice
Also called TensioMed® Arteriograph™, Pulse wave velocity, Arterial Stiffness Monitor
The following will be measured: brachial systolic and diastolic bp, heart rate, mean arterial bp, pulse pressure, brachial augmentation index (difference between the amplitudes of the late (backward) systolic wave (P2) and the early (forward) systolic wave (P1) over the pulse pressure x 100), central augmentation, ejection duration of the left ventricle, return time (time of the pulse wave travelling from aortic root to the bifurcation and back), aortic pulse wave velocity ( velocity of the pulse wave in the aorta), central systolic bp, central pulse pressure and diastolic reflection area (provides information about the quality of diastolic filling in the coronary arteries).
We will perform an arterial age assessment. Patients are given a feedback form with their results to give to their general. Those with increased arterial stiffness will be tested for serum calcium and phosphate levels, and audited to ensure that a statin is commenced if not contraindicated.
| Study group | Role | What they receive |
|---|---|---|
| Arterial stiffness: CKDu patients | Cohort of 50 patients with CKD of unknown aetiology Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. Receives: Device: Arterial Stiffness Assessment | |
| Arterial stiffness: CKD known cause | Cohort of 50 patients with CKD of known cause Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. Receives: Device: Arterial Stiffness Assessment | |
| Arterial Stiffness: Healthy Sri Lankan volunteers | Cohort of 50 participants who are healthy Sri Lankan volunteers Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. Receives: Device: Arterial Stiffness Assessment | |
| 2nd aim: 250 CKDu patients for investigation of aetiology | To recruit a cohort of up to 250 CKDu patients from specific CKDu clinics in Anuradhapura and Padavi-Sri Pura for detailed history, basic anthropometric tests, and further analysis of serum, and urine. Analysis for biomarkers of kidney damage, proteomics, exosomes, and DNA adducts will be used to seek information that may complement already collected data and help refine aetiological hypotheses. Inclusion and Exclusion criteria as per CKDu cases in cohort 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial stiffness
Arterial stiffness will be measured using the TensioMed® Arteriograph™. Damage to large arteries contributes to increased cardiovascular risk in CKD. Atherosclerosis is the most frequent cause of arterial damage but medial calcification seen in CKD also leads to arterial stiffening. This stiffening causes elevated systolic blood pressure, increased left ventricular workload and the gradual development of LVH, and also a fall in diastolic blood pressure impairing coronary blood flow. Arterial calcification and stiffness are independent predictors of all-cause and cardiovascular mortality in CKD patients. It is unclear whether the CVD risk associated with CKDu is the same as it is for CKD of known cause. We plan to measure arterial stiffness in both CKD and CKDu patients. We will compare stiffness measurements in CKD of unknown cause with those of a well characterised cohort of CKD patients in Edinburgh. Healthy Sri Lankan volunteers will give an assessment of 'background stiffness'.
Measured: 3 months
Secondary outcomes (1)
Biomarkers of renal disease and DNA adducts
As the aetiology of CKDu remains unknown, we will collect blood and urine samples from a cohort of p to 259 CKDu patients to explore the aetiology further. These samples will be analysed for biomarkers of kidney damage, proteomics, exosomes, and DNA adducts.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2014 (estimated)
- Study startSep 2014
- Primary completion1 May 2017
- Study completion1 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CKDuStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Rajarata University, Sri Lanka
- Responsible party
- Sponsor
- Investigators
- Michael Eddleston, MA PhD FRCPEdin, Principal investigator, University of EdinburghNeeraj Dhaun, PhD MRCP, Study director, University of EdinburghSisira Siribaddana, MD FCCP, Study director, Rajarata University, Sri Lanka
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02226055
- Sponsor's protocol ID
- UoECKDu1
- Status last verified
- Oct 2017
- First submitted
- 25 Aug 2014
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Cardiovascular Risk and Aetiology of CKDu in Sri Lanka
- ClinicalTrials.gov ID
- NCT02226055
- Acronym / sponsor ID
- UoECKDu1
- Conditions
- CKDu, Arterial Stiffness, Proteinuria, Serum Creatinine, Urinary Biomarkers, DNA Adducts
- Keywords
- Chronic kidney disease of unknown origin, Chronic kidney disease of unknown aetiology, Sri Lanka, CKDu, Arterial stiffness, Cardiovascular risk, North Central Province
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Rajarata University, Sri Lanka
- Study start
- Sep 2014
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 26 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- We hypothesise that CKDu patients will have increased arterial stiffness and thus increased all-cause and cardiovascular mortality. The first objective of this study is to recruit a cohort of ~ 50 CKDu patients who attend the CKDu clinic in Anuradhapura, and measure their arterial stiffness using the TensioMed® Arteriograph™ (details below). We will recruit an age, sex and blood pressure matched control group of healthy Sri Lankans (consenting visitors with patients both to clinic and as inpatients), and if possible, a second control group, similarly age, sex and blood pressure matched, who have CKD of known causes and attend general renal clinic in Anuradhapura.
- We hypothesise that detailed renal analysis will give insight into the aetiology of CKDu in the North Central Province of Sri Lanka. The second objective of the study is to recruit up to 250 CKDu patients and to characterize their disease profile using analysis serum and urine renal biomarkers, exosomes, proteomics and DNA adducts.
Detailed description
Chronic kidney disease (CKD) is one of the leading causes of hospital admission, clinic attendance and mortality in some provinces of Sri Lanka. In central and southern provinces increased incidence is attributed to type-2 diabetes and hypertension; however, this is not the case in North Central Province (NCP) where CKD of unknown aetiology (CKDu) is the commonest diagnosis. A recent World Health Organisation (WHO) investigation concluded that at least 8,000 people have CKDu2.
First recognized in the early nineties, much work has been done to try to characterise the disease however results are conflicting. Most suggest male paddy farmers working in rural areas of the NCP are worst affected, presenting in their fifth decade with end stage renal failure. However, a recent WHO study revealed higher prevalence in females, although more severe renal impairment was more common in men.
Risk factors include inhabiting NCP > five years, inhabiting the 'dry zone', reduced BMI, lower socio-economic class, and exposure to agrochemicals. There has been suggestion of a genetic link although positive family history is limited to one generation, with no evidence of mendelian progression. Epidemiological studies reveal a clustered geographical distribution with areas such as Medawachchiya, Padaviya and Girandurukotte most affected. High prevalence areas encompass a well-developed irrigation system used for agricultural purposes.
Renal biopsies show tubulointerstitial disease with tubular atrophy, interstitial mononuclear cell infiltration, interstitial fibrosis but no immune-complex deposition on immunofluorescence. This supports a toxin-mediated process.
Many aetiologies have been considered including exposure to heavy metals (cadmium, arsenic) and their chelation by herbicides, fluro-aluminium complexes, agricultural pesticides, mycotoxins, and herbal medicines. Selenium deficiency and genetic susceptibility may be predisposing factors. The true aetiology is likely multifactorial.
The multi-system impact of CKDu has yet to be fully realised. Epidemiological and clinical data show that damage to large arteries contributes to the increased cardiovascular risk observed in CKD. Atherosclerosis is the most frequent cause of arterial damage but the medial calcification seen in CKD also leads to arterial stiffening. This stiffening causes elevation in systolic blood pressure, increasing left ventricular workload with the gradual development of LVH, and also a fall in diastolic blood pressure impairing coronary blood flow. Arterial calcification and stiffness are independent predictors of all-cause and cardiovascular mortality in patients with CKD. Arterial stiffness will be compared in CKDu patients, healthy Sri Lankan controls and CKD patients both in Sri Lanka and Scotland.
We will perform a prospective observational study of up to 250 patients with CKDu presenting to renal clinics in Teaching Hospital, Anuradhapura. Patient history, basic anthropometric measurements, and simple non-invasive tests (e.g. blood pressure and arterial stiffness) will be performed. Urine, serum and plasma samples will be collected for quantitative PCR, and further analysis for biomarkers of renal injury, exosomes, proteomics and any DNA-adducts. Patients will be graded using the WHO CKDu grading system. When a renal biopsy is performed, a copy of the light microscopy findings will be obtained. Comparisons of interest will be tested via paired t-tests with statistical significance taken at 5%.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arterial stiffness: CKDu patients | – | Device: Arterial Stiffness AssessmentCohort of 50 patients with CKD of unknown aetiology Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. |
| Arterial stiffness: CKD known cause | – | Device: Arterial Stiffness AssessmentCohort of 50 patients with CKD of known cause Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. |
| Arterial Stiffness: Healthy Sri Lankan volunteers | – | Device: Arterial Stiffness AssessmentCohort of 50 participants who are healthy Sri Lankan volunteers Inclusion and exclusion criteria below Measure of arterial stiffness using pulse wave velocity technology Assessment of BMI, central and brachial blood pressure, arterial stiffness and 'arterial age' will be made and fed back to the patient. this information will be given in a 'results sheet' that the participant will be encouraged to give to their Gp for further treatments required. |
| 2nd aim: 250 CKDu patients for investigation of aetiology | – | –To recruit a cohort of up to 250 CKDu patients from specific CKDu clinics in Anuradhapura and Padavi-Sri Pura for detailed history, basic anthropometric tests, and further analysis of serum, and urine. Analysis for biomarkers of kidney damage, proteomics, exosomes, and DNA adducts will be used to seek information that may complement already collected data and help refine aetiological hypotheses. Inclusion and Exclusion criteria as per CKDu cases in cohort 1 |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending clinics or admitted to hospital during Aug 2014 to Oct 2014 with CKDu (Chronic kidney disease of unknown origin). Subjects must be aged 18 to 85 with evidence of renal dysfunction and no other obvious cause noted (see inclusion/exclusion criteria above). Control groups will be sought for the measure of arterial stiffness: Sri Lankan CKD of known cause, Sri Lankan healthy volunteers. Our controls will be age, sex and blood pressure matched to the cases.
Key inclusion criteria (12 listed)
- Age 18- 85 years
- Attend CKDu clinic in Anuradhapura or Padavi-Sri Pura
- Evidence of renal dysfunction: proteinuria, raised serum creatinine
- Able to understand information given and happy to give consent
- Age 18- 85 years
Key exclusion criteria (13 listed)
- Subjects who are on dialysis
- History of diabetes
- History of major cardiac (including MI), respiratory (including asthma \& COPD) or neurological disease
- Pregnant
- History of significant hypertension (>140/90mmHg despite anti-hypertensives or >160/100mmHg untreated)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Stiffness AssessmentAlso: TensioMed® Arteriograph™, Pulse wave velocity, Arterial Stiffness MonitorThe following will be measured: brachial systolic and diastolic bp, heart rate, mean arterial bp, pulse pressure, brachial augmentation index (difference between the amplitudes of the late (backward) systolic wave (P2) and the early (forward) systolic wave (P1) over the pulse pressure x 100), central augmentation, ejection duration of the left ventricle, return time (time of the pulse wave travelling from aortic root to the bifurcation and back), aortic pulse wave velocity ( velocity of the pulse wave in the aorta), central systolic bp, central pulse pressure and diastolic reflection area (provides information about the quality of diastolic filling in the coronary arteries). We will perform an arterial age assessment. Patients are given a feedback form with their results to give to their general. Those with increased arterial stiffness will be tested for serum calcium and phosphate levels, and audited to ensure that a statin is commenced if not contraindicated. | Device | Arterial Stiffness: Healthy Sri Lankan volunteers, Arterial stiffness: CKD known cause, Arterial stiffness: CKDu patients |
Primary outcome
Arterial stiffness
Time frame: 3 months
Arterial stiffness will be measured using the TensioMed® Arteriograph™. Damage to large arteries contributes to increased cardiovascular risk in CKD. Atherosclerosis is the most frequent cause of arterial damage but medial calcification seen in CKD also leads to arterial stiffening. This stiffening causes elevated systolic blood pressure, increased left ventricular workload and the gradual development of LVH, and also a fall in diastolic blood pressure impairing coronary blood flow. Arterial calcification and stiffness are independent predictors of all-cause and cardiovascular mortality in CKD patients. It is unclear whether the CVD risk associated with CKDu is the same as it is for CKD of known cause. We plan to measure arterial stiffness in both CKD and CKDu patients. We will compare stiffness measurements in CKD of unknown cause with those of a well characterised cohort of CKD patients in Edinburgh. Healthy Sri Lankan volunteers will give an assessment of 'background stiffness'.
1 secondary outcome
Biomarkers of renal disease and DNA adducts
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2017.
- Clinical review CKDuLink provided by the sponsor.
- WHO + Sri Lankan Ministry of Health collaborative studyLink provided by the sponsor.
- Oliver JJ, Webb DJ. Noninvasive assessment of arterial stiffness and risk of atherosclerotic events. Arterioscler Thromb Vasc Biol. Apr 1 2003;23(4):554-566Link provided by the sponsor.
- Sarnak MJ, Levey AS et al. Kidney disease as a risk factor for development of cardiovascular disease: a statement from the American Heart Association Councils on Kidney in Cardiovascular Disease, High Blood Pressure Research,Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Eddleston, MA PhD FRCPEdin principal investigator
University of Edinburgh
Neeraj Dhaun, PhD MRCP study director
University of Edinburgh
Sisira Siribaddana, MD FCCP study director
Rajarata University, Sri Lanka
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CKDu and Arterial Stiffness, run by University of Edinburgh at 1 site in Sri Lanka.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sri Lanka. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial stiffness (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2017.