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Trial registered on ANZCTR
Registration number
ACTRN12619000736145
Ethics application status
Approved
Date submitted
8/05/2019
Date registered
16/05/2019
Date last updated
4/10/2022
Date data sharing statement initially provided
16/05/2019
Date results information initially provided
4/10/2022
Type of registration
Prospectively registered
Titles & IDs
Public title
Vitamin C supplementation of myeloma patients undergoing stem cell transplantation
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Scientific title
Vitamin C supplementation of myeloma patients undergoing stem cell transplantation: a pilot study to evaluate effect on vitamin C status
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Secondary ID [1]
298181
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None
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Universal Trial Number (UTN)
U1111-1231-2396
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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:
Myeloma
312764
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Condition category
Condition code
Cancer
311261
311261
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0
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Myeloma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Vitamin C tablets: 1g twice daily for 5 weeks
Commencing one week prior to HSCT
Adherence monitored by tablet return and plasma levels
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Intervention code [1]
314412
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Treatment: Other
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Comparator / control treatment
Chewable placebo tablets matched for taste and administered as above
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Control group
Placebo
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Outcomes
Primary outcome [1]
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To determine the proportion of participants who achieve and maintain adequate levels of vitamin C, defined as a minimum level of 50 µmol/L plasma vitamin C.
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Assessment method [1]
320001
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Timepoint [1]
320001
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Weekly assessments over 5 weeks (and after 2 week washout for a subset of patients)
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Secondary outcome [1]
370162
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To assess biomarkers of inflammation (exploratory, e.g. CRP, procalcitonin, cell counts and differentials).
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Assessment method [1]
370162
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Timepoint [1]
370162
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weekly assessments over 5 weeks (and after 2 week washout for a subset of patients).
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Secondary outcome [2]
370163
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To assess the composite of incidence and severity of infectious episodes (febrile neutropenia), as assessed by presence of fever (thermometer >38 degrees Celsius) and plasma C-reactive protein levels (>50 mg/L).
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Assessment method [2]
370163
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Timepoint [2]
370163
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Weekly assessments carried out over 5 weeks
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Secondary outcome [3]
370164
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To assess the composite of incidence and severity of oral mucositis using the WHO oral toxicity scale
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Assessment method [3]
370164
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Timepoint [3]
370164
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weekly assessments over 5 weeks
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Secondary outcome [4]
370165
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To assess health-related quality of life using the EORTC QLQ C30 form
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Assessment method [4]
370165
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Timepoint [4]
370165
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weekly assessments over 5 weeks
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Eligibility
Key inclusion criteria
1. Myeloma patient scheduled for HSCT
2. Aged 18 years and over
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Not able to provide informed consent
2. Poor renal function (creatinine clearance <10 mls/sec or glomerular filtration rate <15)
3. Haemochromatosis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
1/07/2019
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Actual
26/08/2019
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Date of last participant enrolment
Anticipated
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Actual
23/12/2021
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Date of last data collection
Anticipated
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Actual
23/12/2021
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Sample size
Target
34
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Accrual to date
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Final
20
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Recruitment outside Australia
Country [1]
21459
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New Zealand
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State/province [1]
21459
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Funding & Sponsors
Funding source category [1]
302721
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Charities/Societies/Foundations
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Name [1]
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Richdale Charitable Trust
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Address [1]
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Richdale Charitable Trust
c/o University of Otago,
PO Box 56.
Dunedin 9054
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Country [1]
302721
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New Zealand
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Primary sponsor type
University
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Name
University of Otago
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Address
University of Otago,
PO Box 56.
Dunedin 9054
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Country
New Zealand
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Secondary sponsor category [1]
302651
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None
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Name [1]
302651
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Address [1]
302651
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Country [1]
302651
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303326
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HDEC Central committee
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Ethics committee address [1]
303326
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Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
303326
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New Zealand
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Date submitted for ethics approval [1]
303326
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Approval date [1]
303326
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07/05/2019
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Ethics approval number [1]
303326
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Summary
Brief summary
Haematopoietic stem cell transplantation, in conjunction with chemotherapy, is a standard treatment for patients with myeloma. However, stem cell transplantation can have major treatment-related complications, including increased risk of infection and inflammatory conditions, as well as a decrease in quality of life. Vitamin C is known to exhibit antioxidant and anti-inflammatory functions and is required for optimal immune system functioning. Significantly decreased plasma vitamin C concentrations have been observed in myeloma patients undergoing conditioning chemotherapy followed by stem cell transplantation.
The purpose of this study is to investigate the effect of oral vitamin C supplementation of myeloma patients undergoing stem cell transplantation on plasma vitamin C status. The effect of supplementation on the incidence and severity of severe infection and oral mucositis (inflammation of membranes lining the digestive tract), and changes in patient quality of life will also be monitored in comparison with a placebo.
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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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A/Prof Anitra Carr
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Address
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University of Otago, Christchurch
PO Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 33640649
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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A/Prof Anitra Carr
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Address
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University of Otago, Christchurch
PO Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 33640649
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Fax
93287
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Email
93287
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[email protected]
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Contact person for scientific queries
Name
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A/Prof Anitra Carr
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Address
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University of Otago, Christchurch
PO Box 4345
Christchurch 8140
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Country
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New Zealand
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Phone
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+64 33640649
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Fax
93288
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Email
93288
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Study results article
Yes
Carr, A.C.; Vlasiuk, E.; Zawari, M.; Meijer, N.; L...
[
More Details
]
377557-(Uploaded-03-10-2022-13-42-56)-Journal results publication.pdf
Documents added automatically
No additional documents have been identified.
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