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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01170468
• Other study ID #: RAC 2101040
• Status: Terminated
• Phase: Phase 3
• First received: July 25, 2010
• Last updated: March 6, 2018
• Start date: December 2011
• Est. completion date: January 15, 2014

Study information

• Verified date: March 2018
• Source: King Faisal Specialist Hospital & Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: January 15, 2014
• Est. primary completion date: January 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Vitamin D3
Vitamin D3 5000 IU orally, daily for 2 years
• Placebo
Placebo orally, daily for 2 years

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