A randomised control trial of high dose oral vitamin D in type 2 diabetes

A randomised control trial of high dose cholecalciferol in type 2 diabetes to assess C-peptide secretion.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001023943

Enrollment

Registered

2011-09-26

Start date

2008-01-08

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The aim was to investigate the effect of high dose oral cholecalciferol (vitamin D3) on pancreatic beta-cell function and glycemia in adults with type 2 diabetes. The hypothesis was that vitamin D would improve beta-cell function and glycemia. Beta-cell function was assessed by measuring glucagon stimulated C-peptide. Insulin resistance was measured by calculating a HOMA-IR index from plasma insulin and glucose levels. Glycemia was assessed by measuring fasting plasma glucose, post-prandial capillary glucose and serum glycosylated haemaglobin.

Interventions

Oral Cholecalciferol: 10,000 IU/ day for 2 weeks then 6000 IU/ day for 22 weeks

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

diabetes diagnosed in the preceding 12 months, age 30- 60, not on insulin treatment, serum vitamin 25-D3 28-85nmol/L glycated hemoglobin (HbA1c) < 8%.

Exclusion criteria

insulin treatment, liver impairment, renal impairment (eGFR <50ml/min), hyperparathyroidism, family or personal history of renal calculi, history of recurrent falls, use of a gait aid, past history of a fragility fracture, personal or family history of osteoporosis and current treatment with oral prednisolone, methotrexate or other immunosuppressive drugs.

Outcome results