Does Vitamin D Improve Glycemic Control in Type II DM? | NCT01170442

Studies
Does Vitamin D Improve Glycemic Control in Type II DM?

NCT01170442

Sponsor

King Faisal Specialist Hospital & Research Center

Status

Terminated

Last Update Posted

Apr 1, 2015Estimated

Enrollment

25Actual

Phase

Phase 3

Conditions

Diabetes Mellitus
Vitamin D Deficiency

Interventions

vitamin D3 2000 IU
vitamin D3 5000 IU
Placebo

Countries

Saudi Arabia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

In adequate enrollment

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Jul 25, 2010

First Submission Date that Met QC Criteria

Jul 26, 2010

First Posted Date

Jul 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2015

Last Update Posted Date

Apr 1, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Muhammad Maher Hammami, Chairman, Department of Clinical Studies & Empirical Ethics, King Faisal Specialist Hospital & Research CenterPrincipal Investigator

Lead Sponsor

King Faisal Specialist Hospital & Research CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
vitamin D3 2000 IU	Experimental	Drug: vitamin D3 2000 IU
vitamin D3 5000 IU	Experimental	Drug: vitamin D3 5000 IU
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitamin D3 2000 IU	Drug	vitamin D3 2000 IU orally, daily for 6 months	vitamin D3 2000 IU

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Area under the curve of HA1C.		6 months

Secondary Outcomes

Measure	Description	Time Frame
Area under the curve for BP		6 months
area under the curve of weight		6 months
area under the curve for 25 OH vitamin D level

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Muhammad M Hammami, MD, PhD	King Faisal Specialist Hospital & Research Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
King Faisal Specialist Hospital & Research Center		Riyadh		11211	Saudi Arabia

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D014808	Vitamin D Deficiency

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002762	Cholecalciferol

Ancestor Terms

ID	Term
D002782	Cholestenes
D002776	Cholestanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided