Effect of vitamin D supplementation on glucose control and inflammatory response in type II diabetic patients.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000714886

Enrollment

Registered

2012-07-04

Start date

2011-11-28

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

Diabetes Mellitus increases both morbidity and mortality due to the long term effects of high blood sugar on kidneys, eyes, and heart. Some studies have described an important role for vitamin D in blood sugar control. In this study, our object is to detect if vitamin D supplementation in vitamin D deficient type II diabetic patients has beneficial effects on sugar control.

Interventions

Arm 1: Vitamin D3 (Cholecalciferol) capsules. (5000 IU/day) for 12 weeks.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

21 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adult (aged 21-75 year-old) at start of screening. * Type II Diabetic patients. * A1C level (> or =) 6 within the last 3 months. * Insulin Resistance based on Homeostatic model assessment (HOMA-IR) (> or =) 2 * Serum 25-hydroxyvitamin D level (25(OH)D) level < (20 ng/ml) (50 nmol/l) * Normal kidney function (eGFR > 90) using CKD-EPI formula * On a stable oral hypoglycemic drug regimen for at least 30 days prior to screening. Those who are on thiazolidinedione should be on stable regimen for at least 6 months prior to screening. * On stable regimen of lipid lowering drug for at least 30 days prior to screening or not on one at all. * On stable regimen of antihypertensive drugs for at least 30 days prior to screening or not on one at all.

Exclusion criteria

1)History of any of the following diseases: A) Chronic kidney diseases eGFR < 90 B) Chronic liver disease. C) Congestive heart failure. D) Myocardial infarction (MI) within the last 6 months. E) History of cerebrovascular accident. F) Hypercalcemia (serum calcium > 10.2 mg/dl) G) Proteinurea (> 3.5 g/24 hours) H) Autoimmune or inflammatory diseases [(e.g. sarcoidosis, systemic lupus erythematous (SLE), rheumatoid arthritis (RA)]. I) Gastrointestinal malabsorption disorders (e.g. celiac, crohn’s disease) J) Primary parathyroid disorders. K) malignancy 2) Currently taking any of the following drugs: A) Insulin. B) Activated Vitamin D analogs or nutritional vitamin D agents > 800 IU/day C) Glucocorticoid D) Antiepeleptic (e.g. phenytoin, phosphenytoin, barbiturate, primidone) E) Carbamezapine F) Digoxin G) Cholestyramine H) Orlistat 3) History of gastric bypass surgery or removal of part of stomach or small intestine. 4) Pregnant or breastfeeding.

Outcome results