Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000428066
Ethics application status
Approved
Date submitted
20/05/2010
Date registered
26/05/2010
Date last updated
26/05/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does amiloride modify the increased urine output that occurs with lithium treatment in individuals with a mood disorder?
Scientific title
A randomised double blind, placebo controlled, cross-over study of the effect of amiloride over 6 weeks, on renal water handling in individuals with a bipolar or unipolar disorder, requiring lithium therapy
Secondary ID [1] 974 0
CRG060500004
Cochrane Renal Group
Universal Trial Number (UTN)
Trial acronym
Lithium and amiloride therapy
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lithium induced nephrogenic diabetes insipidus 243635 0
Condition category
Condition code
Renal and Urogenital 257540 257540 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A double blind randomised cross over study of amiloride or placebo on nephrogenic diabetes insipdus in patients on long term lithium therapy.
Amiloride or placebo will be initially administered at 5mg tablet per day for the first week and then increased to 10mg (2 tablets) daily if tolerated. Amiloride will be administered for 6 weeks. This is then followed by a 6 week wash out period and the alternate tablet administered.
Intervention code [1] 256502 0
Treatment: Drugs
Comparator / control treatment
An inert calcium tablet, initially once daily for the first week then increased to 2 tablets daily for 5 weeks ( a total of 6 weeks)
Control group
Placebo

Outcomes
Primary outcome [1] 240713 0
Modification of urinary concentrating ability and associated changes in urinary aquaporin excretion.
Urinary concentrating ability is assessed using a standard overnight water deprivation study with the morning urine collected and urine osmolaity measured. This is then followed by the adminstration of desmopressin (dDAVP - synthetic anti-diuretic hormone) intra-nasally and urine samples collected at 2,4, and 6hours to measure maximal urine osmolality.
Timepoint [1] 240713 0
Baseline and 6 weeks after each treatment. A total of 4 time points.
Primary outcome [2] 258528 0
Urine aquaporin 2 (AQP2) concentration is measured at the same time points using an in house immunoassay.
Timepoint [2] 258528 0
Baseline and 6 weeks after each treatment. A total of 4 time points.
Secondary outcome [1] 257369 0
None
Timepoint [1] 257369 0
Nil

Eligibility
Key inclusion criteria
Inclusion criteria.
All patients aged 18 to 60, with a bipolar or unipolar affective disorder requiring the commencement of lithium to manage their psychiatric disorder, and who are able to give informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria.
Any individual who is unable to give informed consent.
Any patients with evidence of renal impairment (plasma creatinine > 0.12 mmol/l)
Any patient unable to comply with a fluid restriction.
Any previous exposure to lithium
Pregnancy, thyroid disease.
Any contraindication to amiloride.
Thiazide or Angiotensin converting enzyme inhibitors, requirement for potassium supplements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants were recruited from a larger cross-sectional study investigating urinary concentrating ability and urinary aquaporin excretion in subjects on lithium therapy.. Participants were randomly allocated to placebo or amiloride for 6 weeks and then following a 6 week wash out were given the second therapy.
Allocation was done by contacting a 3rd party who held the allocation schedule
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation was done by a 3rd party using a computer generated code (PRISM 4)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
10
Accrual to date
Final
Recruitment outside Australia
Country [1] 1986 0
New Zealand
State/province [1] 1986 0

Funding & Sponsors
Funding source category [1] 243582 0
Government body
Name [1] 243582 0
Health Research Council of New Zealand
Country [1] 243582 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council of New Zealand
Address
110 Stanley Street
Auckland 1010
Country
New Zealand
Secondary sponsor category [1] 256253 0
None
Name [1] 256253 0
Address [1] 256253 0
Country [1] 256253 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258999 0
Lower South Regional Ethics Committee
Ethics committee address [1] 258999 0
Ethics committee country [1] 258999 0
New Zealand
Date submitted for ethics approval [1] 258999 0
Approval date [1] 258999 0
01/11/2004
Ethics approval number [1] 258999 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30123 0
Address 30123 0
Country 30123 0
Phone 30123 0
Fax 30123 0
Email 30123 0
Contact person for public queries
Name 13370 0
Prof, Robert, Walker
Address 13370 0
Head of Department (HOD) and Consultant Nephrologist, Medical & Surgical Sciences, Dunedin School of Medicine, University of Otago, PO Box 913 Dunedin 9054, New Zealand
Country 13370 0
New Zealand
Phone 13370 0
+64 3 4740999
Fax 13370 0
Email 13370 0
[email protected]
Contact person for scientific queries
Name 4298 0
Prof, Robert, Walker
Address 4298 0
HOD, Medical & Surgical Sciences, Dunedin School of Medicine, PO Box 913 Dunedin 9054, New Zealand
Country 4298 0
New Zealand
Phone 4298 0
+64 3 47470999
Fax 4298 0
Email 4298 0
[email protected]

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
No additional documents have been identified.