Does Vitamin D Improve Glycemic Control in Type II DM?

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170442
• Other study ID #: RAC 2101039
• Status: Terminated
• Phase: Phase 3
• First received: July 25, 2010
• Last updated: March 31, 2015
• Start date: December 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: National Committee of Biological and Medical Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Vitamin D Deficiency

Intervention

Drug:
• vitamin D3 2000 IU
vitamin D3 2000 IU orally, daily for 6 months
• vitamin D3 5000 IU
vitamin D3 5000 IU orally, daily for 6 months
• Placebo
placebo orally, daily for six months

Locations

Country	Name	City	State
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
King Faisal Specialist Hospital & Research Center

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve of HA1C.		6 months	No
Secondary	Area under the curve for BP		6 months	No
Secondary	area under the curve of weight		6 months	No
Secondary	area under the curve for 25 OH vitamin D level		6 months	No
Secondary	area under the curve of fasting blood glucose		6 months	No
Secondary	area under the curve of 2 hour post breakfast glucose		6 months	No
Secondary	fasting insulin to glucose ratio		6 months	No
Secondary	incidence of hypercalcemia		6 months	Yes
Secondary	incidence of hypercalciuria		6 months	Yes