Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000434594
Ethics application status
Approved
Date submitted
6/10/2006
Date registered
10/10/2006
Date last updated
16/05/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Vitamin D Time-Course Pilot Study
Scientific title
Time-course of parathyroid hormone change following vitamin D supplementation in vitamin D insufficient elderly: a pilot study.
Secondary ID [1] 289232 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Vitamin D insufficiency 1406 0
Condition category
Condition code
Metabolic and Endocrine 1501 1501 0 0
Other metabolic and endocrine disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
One of three doses of oral calciferol (Vitamin D3):
1. 500 000 iu followed by monthly placebo for 8 months.
2. 500 000 iu followed by monthly 50 000 iu for 8 months.
3. 50 000 iu monthly for 9 months.
Intervention code [1] 1391 0
Treatment: Drugs
Comparator / control treatment
Placebo
Control group
Dose comparison

Outcomes
Primary outcome [1] 2072 0
Time to nadir of change in parathyroid hormone
Timepoint [1] 2072 0
Blood measurements taken at baseline and months 1, 3, 7, and 9.
Secondary outcome [1] 3579 0
Integrated response of parathyroid hormone (area under the curve), from blood measurements
Timepoint [1] 3579 0
Taken at baseline and months 1, 3, 7, and 9.
Secondary outcome [2] 3580 0
Serum 25(OH)D (from blood measurements taken at baseline and months 1, 3, 7, and 9)
Timepoint [2] 3580 0
Taken at baseline and months 1, 3, 7, and 9.

Eligibility
Key inclusion criteria
Able to provide informed consent and have a high risk of vitamin D insufficiency.
Minimum age
65 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Renal insufficiency (creatinine clearance < 20 ml/min).Major bone disorder, condition or drugs likely to affect calcium, parathyroid hormone or vitamin D metabolism.On high dose vitamin D or long-term steroids.Major systemic illness with a prognosis of 6 months or less.

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)
Random allocation of participants and labelling of medications with participant number completed by individuals not involved with study participants. Medications then administered by a study researcher who is unaware of the contents. Participants also unaware of which dosage they have been assigned.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Minimisation algorithm used to randomly assign participants to one of the three intervention groups and to ensure a balance of gender between each of the three groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Participants and all research staff who have contact with the participants are blinded to to allocation until all data is entered and checked.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/10/2005
Actual
27/10/2005
Date of last participant enrolment
Anticipated
21/04/2006
Actual
16/05/2006
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
63
Recruitment outside Australia
Country [1] 405 0
New Zealand
State/province [1] 405 0

Funding & Sponsors
Funding source category [1] 1636 0
Government body
Name [1] 1636 0
Health Research Council of New Zealand
Country [1] 1636 0
New Zealand
Primary sponsor type
Individual
Name
Professor I.R. Reid
Address
Deputy Dean
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country
New Zealand
Secondary sponsor category [1] 1443 0
University
Name [1] 1443 0
University of Auckland Bone Research Group
Address [1] 1443 0
Department of Medicine
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland 1142
Country [1] 1443 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3081 0
University of Auckland
Ethics committee address [1] 3081 0
Ethics committee country [1] 3081 0
New Zealand
Date submitted for ethics approval [1] 3081 0
Approval date [1] 3081 0
23/09/2005
Ethics approval number [1] 3081 0
NTX/05/09/111

Summary
Brief summary
Elderly volunteers recruited from Older People’s Health wards at Auckland Hospital and randomly assigned to one of three active vitamin D3 treatment regimens. Blood measurements are collected at two monthly intervals and lifestyle and body composition measurements made at baseline and at the end of the study.
Trial website
Trial related presentations / publications
Bacon, C.J., Gamble, G.D., Horne, A.M., Scott, M.A. and Reid, I.R. 2009. High-dose oral vitamin D3 supplementation in the elderly. Osteoporosis International 20(8): 1407-15.
Public notes

Contacts
Principal investigator
Name 27618 0
Prof I.R. Reid
Address 27618 0
Deputy Dean
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92 019
Auckland 1142
Country 27618 0
New Zealand
Phone 27618 0
+64 9 923 6259
Fax 27618 0
Email 27618 0
[email protected]
Contact person for public queries
Name 10580 0
Dr Catherine Bacon
Address 10580 0
Bone Research Group
Department of Medicine
University of Auckland
Private Bag 92 019
Auckland 1020
Country 10580 0
New Zealand
Phone 10580 0
+64 9 3737599 ext. 89785
Fax 10580 0
+64 9 3072865
Email 10580 0
[email protected]
Contact person for scientific queries
Name 1508 0
Prof Professor I.R. Reid
Address 1508 0
Deputy Dean of Faculty of Health & Medical Sciences
University of Auckland
Room 2585 Building 502
Private Bag 92 019
Auckland 1020
Country 1508 0
New Zealand
Phone 1508 0
+64 9 3737599 ext. 86259
Fax 1508 0
Email 1508 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.