Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001182684
Ethics application status
Approved
Date submitted
25/09/2023
Date registered
15/11/2023
Date last updated
15/11/2023
Date data sharing statement initially provided
15/11/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Should pre-procedure oral vitamin C supplementation be considered in people with diabetes undergoing dental procedures?
Scientific title
Should pre-procedure oral vitamin C supplementation be considered in people with diabetes undergoing dental procedures? An observational study into vitamin C levels of people with and without diabetes undergoing dental extraction
Secondary ID [1] 310630 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Dental decay 331507 0
Diabetes 331508 0
Hypovitaminosis C 331509 0
Delayed wound healing 331511 0
Condition category
Condition code
Oral and Gastrointestinal 328242 328242 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Diet and Nutrition 328243 328243 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 328244 328244 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Surgical dental extraction. Fasting blood and urine collection on one occasion to measure paired vitamin C level. The collection of fasting samples will be at the patient's choice - either 1-2 days prior to the extraction appointment, or on the day of the procedure. They will be given food after the fasting samples have been collected.
Participants will be asked to complete a health related questionnaire during their extraction appointment.
Intervention code [1] 327030 0
Early Detection / Screening
Comparator / control treatment
30 people with diabetes will be assessed alongside 30 people without diabetes to compare vitamin C plasma and urine status, inflammatory markers and renal clearance.
Control group
Active

Outcomes
Primary outcome [1] 336112 0
Percentage of patients with hypovitaminosis C
Timepoint [1] 336112 0
Single sample (prevalence study)
Primary outcome [2] 336560 0
Urinary vitamin C / urinary creatinine ratio in patients with hypovitaminosis C
Timepoint [2] 336560 0
Single sample (prevalence study)
Secondary outcome [1] 426875 0
Hospitalisation within 28 days of surgical dental procedure
Timepoint [1] 426875 0
At 1 month post surgical dental procedure
Secondary outcome [2] 427691 0
Subjective assessment of vitamin C deficiency quantified through "Scurvy" visual questionnaire
Timepoint [2] 427691 0
Baseline - (prior to dental extraction)

Eligibility
Key inclusion criteria
People attending the hospital outpatient dental department for full and partial dental extractions (both groups)
- Able to understand study and give full and informed consent
- Agree to collection of age, ethnicity and health data
- Willing / able to give a fasting blood and urine sample

Group of 30 people without diabetes
- HbA1c below 53 mmol/mol (7%)
- not on any diabetes related medication - such as insulin, metformin, sulphonylurea's, DPPIV inhibitors, GLP1 receptor agonists or SGLT2 inhibitors

Group of 30 people with diabetes
- HbA1c of 53 mmol/mol (7%) or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
For both groups of participants:
- Unable to fast prior to the sample collection
- Unable to understand the informed consent or study requirements
- Unwilling to participate

Study design
Purpose
Duration
Selection
Convenience sample
Timing
Statistical methods / analysis
Fishers exact analysis
Mann-Whitney U analysis
Independant t-tests as appropriate

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/11/2023
Actual
Date of last participant enrolment
Anticipated
28/03/2025
Actual
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 25776 0
New Zealand
State/province [1] 25776 0
Canterbury

Funding & Sponsors
Funding source category [1] 314846 0
Charities/Societies/Foundations
Name [1] 314846 0
New Zealand Society for the Study of Diabetes
Country [1] 314846 0
New Zealand
Funding source category [2] 314851 0
Charities/Societies/Foundations
Name [2] 314851 0
Diabetes Christchurch Inc.
Country [2] 314851 0
New Zealand
Primary sponsor type
Hospital
Name
Te Whatu Ora - Waitaha Canterbury
Address
2 Oxford Terrace, Christchurch 8011
Country
New Zealand
Secondary sponsor category [1] 316837 0
University
Name [1] 316837 0
University of Otago, Christchurch
Address [1] 316837 0
2 Riccarton Avenue, Christchurch 8011
Country [1] 316837 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313847 0
Health and Disability Ethics Committee, MInistry of Health
Ethics committee address [1] 313847 0
133 Molesworth Street, Thorndon, Wellington 6011
Ethics committee country [1] 313847 0
New Zealand
Date submitted for ethics approval [1] 313847 0
03/09/2023
Approval date [1] 313847 0
18/09/2023
Ethics approval number [1] 313847 0
2023 EXP 17971 (expedited review does not have a specific ethics committee attached to it)

Summary
Brief summary
This is a feasibility study with the aim of measuring the vitamin C status of people undergoing either a full or partial dental clearance.
We will obtain data from 30 people with diabetes (PwD) and 30 people without diabetes who have been referred to the hospital outpatient dental department.
Our primary objective is to determine the percentage of people undergoing dental clearance who are vitamin C deficient.
We hypothesise that PwD will show evidence of hypovitaminosis C, though a smaller number of people without diabetes may also have low vitamin C levels.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 129538 0
A/Prof Helen Lunt
Address 129538 0
Diabetes outpatient department, Christchurch Hospital, 2 Oxford Terrace, Christchurch 8011
Country 129538 0
New Zealand
Phone 129538 0
+64 3 3640 860
Fax 129538 0
Email 129538 0
[email protected]
Contact person for public queries
Name 129539 0
Leonard Chia
Address 129539 0
Dental outpatient department, Christchurch Hospital, 2 Oxford Terrace, Christchurch 8011
Country 129539 0
New Zealand
Phone 129539 0
+64 3 3640 640
Fax 129539 0
Email 129539 0
[email protected]
Contact person for scientific queries
Name 129540 0
Helen Lunt
Address 129540 0
Diabetes outpatient department, Christchurch Hospital, 2 Oxford Terrace, Christchurch 8011
Country 129540 0
New Zealand
Phone 129540 0
+64 3 3640 860
Fax 129540 0
Email 129540 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is a small feasibility study and we are uncertain whether the small number of participants might allow de-identified data to become re-identifiable.


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.