ClinicalTrials.Veeva

Menu

Does Vitamin D Improve Glycemic Control in Type II DM?

K

King Faisal Specialist Hospital & Research Center

Status and phase

Terminated
Phase 3

Conditions

Vitamin D Deficiency
Diabetes Mellitus

Treatments

Drug: vitamin D3 5000 IU
Drug: Placebo
Drug: vitamin D3 2000 IU

Study type

Interventional

Funder types

Other

Identifiers

NCT01170442
RAC 2101039

Details and patient eligibility

About

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.

Enrollment

25 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

25 participants in 3 patient groups, including a placebo group

vitamin D3 2000 IU
Experimental group
Treatment:
Drug: vitamin D3 2000 IU
vitamin D3 5000 IU
Experimental group
Treatment:
Drug: vitamin D3 5000 IU
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems