Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes

Metabolic Effects of Vitamin D in Patients With Type 2 Diabetes - a Randomized Controlled Trial

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00812578

Acronym

ProjectD

Enrollment

Registered

2008-12-22

Start date

2008-12-31

Completion date

2010-06-30

Last updated

2010-07-12

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

Conditions

Type 2 Diabetes, Vitamin D Insufficiency

Keywords

Type 2 diabetes, Vitamin D insufficiency, Insulin secretion, Insulin sensitivity, Pulsatility

Brief summary

The purpose of the study is to examine the effect on metabolic parameters after 12 weeks of treatment with high dose vitamin D in patients with type 2 diabetes and vitamin D insufficiency.

Detailed description

There is increasing evidence that vitamin D affects the risk of diabetes. The role of vitamin D in type 2 diabetes is suggested by cross sectional studies, where an inverse association between vitamin D status and the development of type 2 diabetes has been found. Moreover supplementation with calcium and vitamin D may attenuate increases in glycemia and insulin resistance in healthy older adults with IFG. However further research is needed to confirm these findings and to determine possible mechanisms of the preventive effect from vitamin D against diabetes. The aim of this study is to examine the effect on metabolic parameters such as glycemic control, lipid status, inflammatory markers, insulin resistance and insulin secretion in patients with type 2 diabetes and vitamin D insufficiency before and after a 12-week period of treatment with high doses of vitamin D.

Interventions

DRUGCholecalciferol

8 tablets equivalent to 280 micrograms for 2 weeks and 4 tablets equivalent to 140 micrograms for 10 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Informed consent * Type 2 diabetes * Patients of Danish extraction * Vitamin D insufficiency (1,25OHvitD \< 50 nmol/l)

Exclusion criteria

* Nephropathy (Urea \> 12 mmol/l) * S-calcium \> 2,52 mmol/L * Primary hyperparathyroidism * Serious disease * Malabsorption * Sarcoidosis * Pregnancy

Design outcomes

Primary

Measure	Time frame
Insulin secretion and insulin resistance	6 hours

Secondary

Measure	Time frame
Glycemic control, lipid status, inflammatory markers, BMD	2 months

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026