Does Vitamin D Reduce Risk of Developing Type II DM in High Risk Individuals

Does Vitamin D Reduce Risk of Developing Type II DM in Prediabetics? A Double Blind Randomized Controlled Trial

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170468

Enrollment

Registered

2010-07-27

Start date

2011-12-31

Completion date

2014-01-15

Last updated

2018-03-07

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

Conditions

Type 2 Diabetes Mellitus

Keywords

Prediabetics, DM, vitamin D

Brief summary

Both vitamin D deficiency and type II DM/prediabetes are highly prevalent. Vitamin D status has been negatively associated with the presence of type II DM and glycemic control. A cause-effect relationship between vitamin D deficiency and the development of type II DM has not been established. The investigators plan to conduct a 2 year, double blind, randomized, placebo controlled trial on the effect of vitamin D3 supplement on the incidence of type II DM in high risk individuals.

Interventions

DRUGVitamin D3

Vitamin D3 5000 IU orally, daily for 2 years

DRUGPlacebo

Placebo orally, daily for 2 years

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Adults living in Riyadh area with impaired fasting glucose or/and impaired glucose tolerance (prediabetics) and total 25 OH vitamin D level between 10-30 nmol/l * 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 granulomatus conditions, liver disease, kidney disease, or diabetes * Don't take anticonvulsants, barbiturates, steroids, or antidiabetic medications.

Design outcomes

Primary

Measure	Time frame	Description
The incidence of DM	2 years	Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.

Secondary

Measure	Time frame	Description
slope of fasting glucose level	2 years	—
slope of 2-hour post challenge glucose level	2 years	—
area under the curve of BP	2 years	—
area under the curve of weight	2 years	—
time to develop DM	2 years	Development of DM diagnosed by glucose levels, fasting and/or 2-hour post 75 mg glucose challenge.
fasting insulin to glucose ratio	2 years	—
incidence of hypercalcemia	2 years	—
incidence of hypercalciuria	2 years	—
area under the curve of 25 OH vitamin D level	2 years	—

Countries

Saudi Arabia

Outcome results

None listed

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