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Trial registered on ANZCTR
Registration number
ACTRN12613000195752
Ethics application status
Approved
Date submitted
14/02/2013
Date registered
19/02/2013
Date last updated
27/07/2016
Type of registration
Prospectively registered
Titles & IDs
Public title
Acetazolamide in lithium-induced nephrogenic diabetes insipidus (NDI).
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Scientific title
The effect of acetazolamide on
lithium-induced Nephrogenic Diabetes Insipidus
in patients with affective disorders:
a pilot study
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Secondary ID [1]
281964
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Lithium-induced nephrogenic diabetes insipidus
288388
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Condition category
Condition code
Renal and Urogenital
288734
288734
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0
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Kidney disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In this pilot study we will evaluate the efficacy of acetazolamide in the treatment of lithium-induced NDI.
Acetazolamide will be commenced at 250mg orally once a day for 7 days, then increased to 250mg orally twice a day for the 2nd week, then as tolerated to 500mg orally twice a week for weeks 3 & 4. If the higher dose is not tolerated, the dose will be lowered back to the tolerated oral dose.Total duration of treatment is 4 weeks.
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Intervention code [1]
286530
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Treatment: Drugs
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Comparator / control treatment
This is a pilot study with the individual acting as their own control.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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A change in urinary concentrating ability. This will measured by a standard water deprivation and urinary concentration test. Following an overnight fast, a baseline urine sample will be collected at 0830. Then 40ug desmopressin (dDAVP) will be administered intranasally. Urine samples will be collected at 2,4 and 6 hours to measure urine osmolality. This will be done at baseline and at the end of 4 week.
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Assessment method [1]
288877
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Timepoint [1]
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at baseline and following 4 weeks of therapy.
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Secondary outcome [1]
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Patients' reported fluid intake and urine output. Clinical assessment at each visit.
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Assessment method [1]
301222
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Timepoint [1]
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At baseline and at each weekly visit for 4 weeks
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Secondary outcome [2]
301277
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Assessment of blood pressure. Clinical assessment at each weekly visit
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Assessment method [2]
301277
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Timepoint [2]
301277
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At baseline and at each weekly vosit for 4 weeks
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Secondary outcome [3]
301278
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Assessment of renal function by routine weekly measurement of plasma creatinine
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Assessment method [3]
301278
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Timepoint [3]
301278
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At baseline and weekly for 4 weeks
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Secondary outcome [4]
301279
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Assessment of plasma lithium concentrations by weekly blood tests.
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Assessment method [4]
301279
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Timepoint [4]
301279
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At baseline and weekly for 4 weeks.
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Eligibility
Key inclusion criteria
stable patients treated with lithium for an affective disorder
men and women
age > 18 years
evidence of lithium- induced nephrogenic diabetes insipidus
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Minimum age
18
Years
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Maximum age
65
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
pregnancy
diabetes mellitus
underlying renal disorders
significant cardiac/pulmonary comorbidity
heart rhythm disorders
side effects of lithium treatment
treatment with hydrochlorothiazide or amiloride in the preceding 2 weeks
concomitant treatment with other diuretics
hypotension (systolic blood pressure < 100 mm Hg)
renal insufficiency
hypo/hyperkalemia
hypercalcaemia
hypo/hyperthyroidism
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A pilot study of individuals with lithium-induced NDI. Each individual acts as their own control with a baseline study before treatment and then a repeat study 4 weeks after acetazolamide therapy. This is an open label pilot study.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
Descriptive statistics
The continuous variables will be presented as means (SD) or as percentages.
Interim analysis
After analyzing three patients in this pilot study results will be analyzed. The main parameter which will be analyzed is maximal urine osmolality. The maximal urine osmolality after acetazolamide treatment will be compared with the maximal urine osmolality before the acetazolamide treatment.
After finishing the study, maximal urine osmolality after acetazolamide treatment will be compared with the maximal urine osmolality before the acetazolamide treatment by using a paired t-test; p-values <0.05 will be considered significant.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Safety concerns
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Date of first participant enrolment
Anticipated
4/03/2013
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Actual
1/05/2013
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Date of last participant enrolment
Anticipated
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Actual
22/05/2013
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Date of last data collection
Anticipated
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Actual
30/08/2013
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Sample size
Target
6
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Accrual to date
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Final
3
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Recruitment outside Australia
Country [1]
4868
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New Zealand
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State/province [1]
4868
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Department of Medicine (Renal) research funds
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Address [1]
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Department of Medicine University of Otago Dunedin PO Box 913 Dunedin NZ 9054
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Country [1]
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New Zealand
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Primary sponsor type
University
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Name
Department of Medicine University of Otago
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Address
Department of Medicine
University of Otago Dunedin
PO Box 913 Dunedin 9054
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Country
New Zealand
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Secondary sponsor category [1]
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None
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Name [1]
285518
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Address [1]
285518
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Country [1]
285518
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288814
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Southern Region Health and Disability Ethics Comittee
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Ethics committee address [1]
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Ministry of Health No 1 The Terrace PO Box 5013 Wellington 6011
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Ethics committee country [1]
288814
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New Zealand
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Date submitted for ethics approval [1]
288814
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14/02/2013
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Approval date [1]
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18/04/2014
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Ethics approval number [1]
288814
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Summary
Brief summary
Lithium is an effective drug for controlling various mood disorders. However it is frequently associated with the development of nephrogenic diabetes inspidus - where the individual is unable to concentrate their urine and so have an increased thirst and pass large quantities of urine. This can be modified by the use of amiloride which blocks the action of lithium in the kidney and corrects the NDI. Acetazolamide also alters kidney handling of lithium and may be more effective in correcting the NDI. We wish to test this in a group of individuals on lithium therapy.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Robert Walker
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Address
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Department of Medicine Dunedin School of Medicine University of Otago PO Box 913 Dunedin 9054
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Country
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New Zealand
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Phone
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+6434740999
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Fax
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+6434747641
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Email
37898
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[email protected]
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Contact person for public queries
Name
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Robert Walker
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Address
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Department of Medicine Dunedin School of Medicine University of Otago PO Box 913 Dunedin 9054
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Country
37899
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New Zealand
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Phone
37899
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+6434740999
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Fax
37899
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+6434747641
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Email
37899
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[email protected]
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Contact person for scientific queries
Name
37900
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Robert Walker
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Address
37900
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Department of Medicine Dunedin School of Medicine University of Otago PO Box 913 Dunedin 9054
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Country
37900
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New Zealand
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Phone
37900
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+6434740999
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Fax
37900
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+6434747641
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Email
37900
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Lithium-induced NDI: Acetazolamide reduces polyuria but does not improve urine concentrating ability.
2017
https://dx.doi.org/10.1152/ajprenal.00147.2017
N.B. These documents automatically identified may not have been verified by the study sponsor.
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