Does Vitamin D Improve Glycemic Control in Type II DM?

Does Vitamin D Improve Glycemic Control in Type II DM? A Double Blind Randomized Controlled Trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170442

Enrollment

Registered

2010-07-27

Start date

2011-12-31

Completion date

2013-12-31

Last updated

2015-04-01

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

Conditions

Diabetes Mellitus, Vitamin D Deficiency

Brief summary

Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. However, a cause-effect relationship between vitamin D deficiency and glycemic control has not been established. The investigators plan to conduct a double blind, randomized, placebo controlled trial on the effect of vitamin D supplementation on glycemic control in Type II DM.

Interventions

DRUGvitamin D3 2000 IU

vitamin D3 2000 IU orally, daily for 6 months

DRUGvitamin D3 5000 IU

vitamin D3 5000 IU orally, daily for 6 months

DRUGPlacebo

placebo orally, daily for six months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Type II diabetics living in Riyadh area who consume no more than one serving of milk/day * Do not take vitamin supplement * Habitually have less than 10 hour of sun exposure per week * Don't suffer from granulomatous conditions, liver disease, or kidney disease * Don't take anticonvulsants, barbiturates, or steroids. * Stable glycemic control (not more than 0.5% difference between current HA1c and a HA1c obtained 2-4 months earlier) * Current HA1c between 6.5 and 8%, and current total 25 OH vitamin D level between 10-30 nmol/L.

Design outcomes

Primary

Measure	Time frame
Area under the curve of HA1C.	6 months

Secondary

Measure	Time frame
area under the curve of weight	6 months
area under the curve for 25 OH vitamin D level	6 months
area under the curve of fasting blood glucose	6 months
Area under the curve for BP	6 months
fasting insulin to glucose ratio	6 months
incidence of hypercalcemia	6 months
incidence of hypercalciuria	6 months
area under the curve of 2 hour post breakfast glucose	6 months

Countries

Saudi Arabia

Outcome results

None listed

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