None listed
Conditions
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.
Interventions
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.
Sponsors
Massey University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
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.
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
Outcome results
None listed