UrolithiasisNCT01349764
Effect of Vitamin D Replacement in Patients With Urolithiasis
An observational study of Urolithiasis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
When Vitamin D replacement is initiated in patients with history of urolithiasis, there will be higher incidence of hypercalciuria but with careful follow-up of these patients, hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of newly diagnosed renal stones will be equivalent to… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urolithiasis
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2011to May 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the MUHC stone clinic and had inadequate vitamin D.
Who may be able to join
- 25-OHD deficiency or insufficiency (defined as serum level <75 nmol/L).
- History of urolithiasis (Calcareous stones).
- 24-hour urinary calcium excretion <7.5 mmol/day (normocalciuric).
- Low fracture risk (estimated by FRAX®, which was developed by WHO).
Who cannot join
- Age < 18 years
- Renal dysfunction (Serum creatinine concentrations of > 150 μmol/L).
- History of non-calcareous stones e.g. uric acid, cystine, or struvite stones.
- Hypercalcemia (serum ionized normalized calcium > 1.32 mmol/L)
- Patients with secondary hypercalciuria e.g. primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or active malignancy.
- Evidence of osteoporosis or intermediate/high fracture risk (estimated by FRAX).
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- Patients taking drugs that could potentially affect urinary calcium excretion (vitamin D, calcium supplement, loop diuretics, steroids, or lithium).
- Evidence of liver dysfunction or other disorders that may cause non-nutritional vitamin D deficiency or abnormal bone development.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Royal Victoria Hospital, McGill University Health Center
Montreal, Quebec, H3A 1A1
About this study
Official title: Effect of Vitamin D Replacement in Vitamin D Deficient Patients With History of Urolithiasis: A Randomized Controlled Trial
When Vitamin D replacement is initiated in patients with history of urolithiasis, there will be higher incidence of hypercalciuria but with careful follow-up of these patients, hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of newly diagnosed renal stones will be equivalent to control groups without Vitamin D replacements.the purpose of the study is to determine the effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters and to evaluate the lithogenic effect of vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible patients will be included in terms of having suboptimal vitamin D with history of calcareous urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided into 2 equal groups depending on whether they will receive vitamin D replacement with follow-up at 3, 6, 12, \& 24 months.
Read the detailed description
During the last year, clinical studies on vitamin D have confirmed the presence of world-wide incidence of vitamin D deficiency. Recently, the investigators detected an incidence of 80% vitamin D deficiency/ insufficiency in patients presenting to our tertiary stone clinic. However, there is no data in the literature regarding the safety of vitamin D replacement in this highly specialized group of patients. Consequently, clinicians are concerned about vitamin D replacement in these patients for fear of increased risk of hypercalciuria and stone formation.
This study aims to determine the effect of vitamin D replacement on patients presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters and secondary stone formation. Eighty- six eligible patients with 25-(OH)D deficiency or insufficiency (defined as serum level <72 nmol/L) with history of calcareous urolithiasis and urinary calcium excretion <7.5 mmol/day will be included in the study.
Eligible patients will be randomly divided into 2 equal groups depending on whether they will receive vitamin D replacement or not. Randomization will be done using a computer-based random number generator. Patients will receive vitamin D3 tablets 10.000 IU twice a week for 8 weeks followed by a maintenance dose of 1.000 IU daily for 21 months. All patients will be subjected to full history taking and clinical examinations, urinalysis and culture when indicated, liver function tests, urea and creatinine, ionized normalized calcium, phosphate, magnesium, uric acid, potassium, PTH, TSH and both forms of vitamin D [25(OH)D and 1, 25 (OH)2D], low dose CT scan to confirm stone free status and baseline bone density scan, together with metabolic stone workup consisting of stone analysis and two 24-hour urine collections for calculation of volume, osmolality, pH, creatinine, urea, calcium, phosphate, chloride, magnesium, sodium, potassium, oxalate, citrate, uric acid, and quantitative cystine. Similar follow-up measures will be done at 3, 6, 12, 18 \& 24 months. At the end of the study, low dose CT scan and bone density scans will be repeated.
Data will be collected and tabulated using the commercially available SPSS software version 17 (SPSSInc, Chicago, IL, USA). Descriptive statistics will be presented in terms of percentage, frequency, means and standard deviations for parametric variables and median with interquartile ranges for non-parametric. Differences between both groups will be compared with the Fisher's exact test for categorical data and Student's t- test for the continuous variables. In addition, interplay of more than 2 variables will be analysed using multivariate logistic-regression. The effect of season of recruitment on and changes in serum 25(OH)D will be evaluated using multivariate analysis of covariance (ANCOVA) with two-tailed p-values less than values 0.05 representing statistical significance. Time to hypercalciuria or time to stone formation c will be analysed using a survival analysis technique and comparison of the 2 groups using a log-rank test.
- Conditions
- Urolithiasis
- Being tested
- Vitamin D3
- Keywords
- vitamin D replacement, Urolithiasis, deficiency, insufficiency
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
| Study group | Role | What they receive |
|---|---|---|
| No vitamin D replacement | The control arm will not receive vitamin D replacement, but patients in both study arms will receive care consistent with best care practices for stone disease. All patients will be evaluated by the stone clinic clinical nutritionist and full nutritional evaluation will be performed. All patients will be advised to maintain adequate hydration (>2L/day), no-added salt diet (Na 80-100mmol/day), low protein diet (1 g/kg/day). Patients with hyperoxaluria will be advised to follow low-oxalate diet. All patients will be advised to maintain moderate calcium intake; 800-1200mg/day. | |
| Vitamin D3 tabs | The active arm of randomization will receive vitamin D repletion in the form of oral vitamin D3 tablets 10 000 IU twice/ week for 8 consecutive weeks, followed by a maintenance dose of 1 000 IU daily for further 22 months. Receives: Drug: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters
Measured: 6 months
Secondary outcomes (1)
The lithogenic effect of vitamin D replacement in terms of development of urolithiasis.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2011 (estimated)
- Study startApr 2011
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Unable to recruit required sample size
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sero Andonian, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Sero Andonian, MD, FRCS (C), Principal investigator, MUHC, Montreal QC, CanadaAhsan Alam, MD, FRCP (C), Study director, MUHC, Montreal QC, CanadaRamsey Sabbagh, MD, FRCP (C), Study director, MUHC, Montreal QC, CanadaBernard Unikowsky, MD, FRCP (C), Study director, MUHC, Montreal QC, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01349764
- Sponsor's protocol ID
- 10-325-BMB
- Status last verified
- May 2016
- First submitted
- 5 May 2011
- Last updated
- 5 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Replacement in Vitamin D Deficient Patients With History of Urolithiasis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01349764
- Acronym / sponsor ID
- 10-325-BMB
- Conditions
- Urolithiasis
- Keywords
- vitamin D replacement, Urolithiasis, deficiency, insufficiency
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Unable to recruit required sample size
- Enrolment
- 10 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 9 May 2011 (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.
When Vitamin D replacement is initiated in patients with history of urolithiasis, there will be higher incidence of hypercalciuria but with careful follow-up of these patients, hypercalciuria could be appropriately managed with thiazide diuretics so that the risk of newly diagnosed renal stones will be equivalent to control groups without Vitamin D replacements.the purpose of the study is to determine the effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters and to evaluate the lithogenic effect of vitamin D replacement in terms of development of urolithiasis. Eighty-six eligible patients will be included in terms of having suboptimal vitamin D with history of calcareous urolithiasis and urinary calcium excretion <7.5 mmol/day. Patients will be randomly divided into 2 equal groups depending on whether they will receive vitamin D replacement with follow-up at 3, 6, 12, \& 24 months.
Detailed description
During the last year, clinical studies on vitamin D have confirmed the presence of world-wide incidence of vitamin D deficiency. Recently, the investigators detected an incidence of 80% vitamin D deficiency/ insufficiency in patients presenting to our tertiary stone clinic. However, there is no data in the literature regarding the safety of vitamin D replacement in this highly specialized group of patients. Consequently, clinicians are concerned about vitamin D replacement in these patients for fear of increased risk of hypercalciuria and stone formation.
This study aims to determine the effect of vitamin D replacement on patients presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters and secondary stone formation. Eighty- six eligible patients with 25-(OH)D deficiency or insufficiency (defined as serum level <72 nmol/L) with history of calcareous urolithiasis and urinary calcium excretion <7.5 mmol/day will be included in the study.
Eligible patients will be randomly divided into 2 equal groups depending on whether they will receive vitamin D replacement or not. Randomization will be done using a computer-based random number generator. Patients will receive vitamin D3 tablets 10.000 IU twice a week for 8 weeks followed by a maintenance dose of 1.000 IU daily for 21 months. All patients will be subjected to full history taking and clinical examinations, urinalysis and culture when indicated, liver function tests, urea and creatinine, ionized normalized calcium, phosphate, magnesium, uric acid, potassium, PTH, TSH and both forms of vitamin D [25(OH)D and 1, 25 (OH)2D], low dose CT scan to confirm stone free status and baseline bone density scan, together with metabolic stone workup consisting of stone analysis and two 24-hour urine collections for calculation of volume, osmolality, pH, creatinine, urea, calcium, phosphate, chloride, magnesium, sodium, potassium, oxalate, citrate, uric acid, and quantitative cystine. Similar follow-up measures will be done at 3, 6, 12, 18 \& 24 months. At the end of the study, low dose CT scan and bone density scans will be repeated.
Data will be collected and tabulated using the commercially available SPSS software version 17 (SPSSInc, Chicago, IL, USA). Descriptive statistics will be presented in terms of percentage, frequency, means and standard deviations for parametric variables and median with interquartile ranges for non-parametric. Differences between both groups will be compared with the Fisher's exact test for categorical data and Student's t- test for the continuous variables. In addition, interplay of more than 2 variables will be analysed using multivariate logistic-regression. The effect of season of recruitment on and changes in serum 25(OH)D will be evaluated using multivariate analysis of covariance (ANCOVA) with two-tailed p-values less than values 0.05 representing statistical significance. Time to hypercalciuria or time to stone formation c will be analysed using a survival analysis technique and comparison of the 2 groups using a log-rank test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No vitamin D replacement | – | –The control arm will not receive vitamin D replacement, but patients in both study arms will receive care consistent with best care practices for stone disease. All patients will be evaluated by the stone clinic clinical nutritionist and full nutritional evaluation will be performed. All patients will be advised to maintain adequate hydration (>2L/day), no-added salt diet (Na 80-100mmol/day), low protein diet (1 g/kg/day). Patients with hyperoxaluria will be advised to follow low-oxalate diet. All patients will be advised to maintain moderate calcium intake; 800-1200mg/day. |
| Vitamin D3 tabs | – | Drug: Vitamin D3The active arm of randomization will receive vitamin D repletion in the form of oral vitamin D3 tablets 10 000 IU twice/ week for 8 consecutive weeks, followed by a maintenance dose of 1 000 IU daily for further 22 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the MUHC stone clinic and had inadequate vitamin D.
Key inclusion criteria (4 listed)
- 25-OHD deficiency or insufficiency (defined as serum level <75 nmol/L).
- History of urolithiasis (Calcareous stones).
- 24-hour urinary calcium excretion <7.5 mmol/day (normocalciuric).
- Low fracture risk (estimated by FRAX®, which was developed by WHO).
Key exclusion criteria (9 listed)
- Age < 18 years
- Renal dysfunction (Serum creatinine concentrations of > 150 μmol/L).
- History of non-calcareous stones e.g. uric acid, cystine, or struvite stones.
- Hypercalcemia (serum ionized normalized calcium > 1.32 mmol/L)
- Patients with secondary hypercalciuria e.g. primary hyperparathyroidism, sarcoidosis, hyperthyroidism, or active malignancy.
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 |
|---|---|---|
| Vitamin D3 | Drug | Vitamin D3 tabs |
Primary outcome
The effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters
Time frame: 6 months
1 secondary outcome
The lithogenic effect of vitamin D replacement in terms of development of urolithiasis.
Time frame: 24 months
Results and safety
The study was stopped early (reason given: Unable to recruit required sample size). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2016.
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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.
Sero Andonian, MD, FRCS (C) principal investigator
MUHC, Montreal QC, Canada
Ahsan Alam, MD, FRCP (C) study director
MUHC, Montreal QC, Canada
Ramsey Sabbagh, MD, FRCP (C) study director
MUHC, Montreal QC, Canada
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 Urolithiasis, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 5 May 2016. 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 Canada. 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 was stopped early (reason given: Unable to recruit required sample size). Results are not available in the source record.
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?
The effect of vitamin D replacement in patients with previous history of urolithiasis presenting to a tertiary stone clinic in terms of changes in 24-hour urine collection parameters (time frame: 6 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 5 May 2016.