Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620001106921
Ethics application status
Approved
Date submitted
31/08/2020
Date registered
26/10/2020
Date last updated
26/10/2020
Date data sharing statement initially provided
26/10/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of vitamin D on glycaemic control in pre-diabetic patients
Scientific title
The effect of vitamin D supplementation on glycaemic control and progression to Type 2 Diabetes Mellitus in pre-diabetic patients – An open-label intervention clinical trial
Secondary ID [1] 302163 0
None
Universal Trial Number (UTN)
U1111-1255-0498
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 318816 0
Vitamin D deficiency 318817 0
Condition category
Condition code
Metabolic and Endocrine 316829 316829 0 0
Diabetes
Diet and Nutrition 316830 316830 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vitamin D supplement - one oral tablet of 50,000IU cholecalciferol (Vitamin D3) dose fortnightly for 9-12 months per clinician discretion. Adherence will be assessed by study tablet return count.
Intervention code [1] 318464 0
Treatment: Other
Intervention code [2] 318465 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324947 0
Glycaemic control (HbA1c) assessed by serum assay
Timepoint [1] 324947 0
Baseline (scheduled GP visit) and end of intervention (9-12 months post enrolment)
Secondary outcome [1] 386282 0
Serum 25(OH)D assessed by serum assay
Timepoint [1] 386282 0
Baseline (scheduled GP visit) and end of intervention (9-12 months post enrolment)
Secondary outcome [2] 386283 0
hs-CRP assessed by serum assay.
Timepoint [2] 386283 0
Baseline (scheduled GP visit) and end of intervention (9-12 months post enrolment)
Secondary outcome [3] 386284 0
Safety measure assessed by serum calcium adjusted for albumin suing serum assay.
Timepoint [3] 386284 0
Baseline (scheduled GP visit) and end of intervention (9-12 months post enrolment)

Eligibility
Key inclusion criteria
Greenstone Family Clinic (Auckland, New Zealand) patients who are pre-diabetic (HbA1c of 41-49 mmol/mol) and have vitamin D deficiency and insufficiency (serum 25(OH)D<75nmol/L) will be eligible for this study.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Volunteers will be excluded per their general practitioner's decision and if they:
• Have illnesses that affect vitamin D metabolism/absorption.
• Take medications that affect vitamin D metabolism/absorption.
• Have hypercalcaemia, hypercalciuria, sarcoidosis, or renal osteodystrophy with hyperphosphatemia.
• Have major systemic illnesses

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
This is an open-label intervention clinical-based trial
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 22898 0
New Zealand
State/province [1] 22898 0
Auckland

Funding & Sponsors
Funding source category [1] 306591 0
University
Name [1] 306591 0
Massey University Research Fund
Country [1] 306591 0
New Zealand
Primary sponsor type
University
Name
Massey University
Address
School of Human Nutrition,
Massey University East Precinct,
Albany Expressway
Albany,
Auckland 0632
Country
New Zealand
Secondary sponsor category [1] 307120 0
None
Name [1] 307120 0
Address [1] 307120 0
Country [1] 307120 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306773 0
Central Health and disability ethics committees (HDECs)
Ethics committee address [1] 306773 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 306773 0
New Zealand
Date submitted for ethics approval [1] 306773 0
10/08/2020
Approval date [1] 306773 0
09/09/2020
Ethics approval number [1] 306773 0
20/CEN/194

Summary
Brief summary
Early identification of pre-diabetes is a key factor in halting the progression of the disease. Lifestyle interventions, including nutritional therapy can halt or reverse pre-diabetes. It appears that vitamin D should be part of the nutrition therapy, but it is not currently recommended, largely due to inconclusive findings of previous trials.

This research aims to investigate the effect of supplementing pre-diabetic patients with vitamin D, on glycaemic control and progression to Type 2 Diabetes Mellitus (T2DM).

Patients of the Greenstone Family Clinic in Auckland who have been identified as being pre-diabetic and at risk of vitamin D deficiency will be included in this study.

As patients are recalled for standard monitoring, they will be invited to participate in the trial by the diabetes nurse during the appointment, and consented at that point if they agree. Then, they will be sent for a blood test to check vitamin D status, hs-CRP, calcium and albumin. If they are identified as being vitamin D deficient they will be included in the trial and will be supplemented with 50,000IU cholecalciferol (Vitamin D3) fortnightly for at least nine months but not more than 12 months per GP prescription. This is a clinical decision made within the practice. After 9 to 12 months, patients will be recalled by the diabetes nurse who will perform her usual recall assessments, including sending the patient for a blood test to check their HbA1c. At this stage, for the purpose of the research, they will also have their vitamin D status, hs-CRP, calcium and albumin measured.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 104978 0
A/Prof Pamela von Hurst
Address 104978 0
School of Human Nutrition,
Level 1, SNW Building,
Massey University East Precinct,
Albany Expressway(SH17),
Albany, Auckland 0632
Country 104978 0
New Zealand
Phone 104978 0
+64 9 414 0800 43657
Fax 104978 0
Email 104978 0
[email protected]
Contact person for public queries
Name 104979 0
Pamela von Hurst
Address 104979 0
School of Human Nutrition,
Level 1, SNW Building,
Massey University East Precinct,
Albany Expressway(SH17),
Albany, Auckland 0632
Country 104979 0
New Zealand
Phone 104979 0
+64 9 414 0800 43657
Fax 104979 0
Email 104979 0
[email protected]
Contact person for scientific queries
Name 104980 0
Pamela von Hurst
Address 104980 0
School of Human Nutrition,
Level 1, SNW Building,
Massey University East Precinct,
Albany Expressway(SH17),
Albany, Auckland 0632
Country 104980 0
New Zealand
Phone 104980 0
+64 9 414 0800 43657
Fax 104980 0
Email 104980 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


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.