Effects of Treating Vitamin D Deficiency in Poorly Controlled Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study will investigate the effect of Vitamin D supplementation in improving
      glucose control with patients with poorly controlled diabetes and concurrent Vitamin D
      deficiency.
    

Detailed description: 
      Subject will undergo screening procedures, subject will have blood drawn from a vein in your
      arm to measure subject's Vitamin D level (about 1 tablespoon).If the subject is eligible
      based on the results of their blood work and the subject agrees to participate in this study,
      the subject will return to the clinic to begin the study. There will be 4 study visits every
      2 months and phone interviews every 2 weeks during the 6 month study. In the beginning (Visit
      1) and end of the study (Visit 4), fasting blood samples will be collected for analysis of
      fasting plasma glucose, %HbAlc (your long-term sugar control over a 3 month period), calcium,
      insulin, and Vitamin D level. Urine samples will be collected to determine urinary
      microalbumin-creatinine ratio (early protein loss in the kidneys). Blood pressure will be
      measured three times with an automatic blood pressure machine. Height and weight will be
      measured. A medical history questionnaire will be completed by subjects that will include
      basic demographics, typical dietary intake, smoking and alcohol history, medical history, as
      well as list of medications and over-the-counter supplements.

      At Visit 1 the subject will be randomized (like the toss of a coin) to receive either a sugar
      pill or a high dose Vitamin D medication, which the subject will take once a week for 8 weeks
      and then once a month for 4 months. The subject will have a 50:50 chance of receiving one or
      the other pill. At Visit 2 and Visit 3, the subject will also get blood work to analyze your
      calcium and Vitamin D level. At each clinic visit, the subject will also have your blood
      sugar and high blood pressure managed closely by the study investigators, both of who are
      doctors (one being a primary care doctor and another being an endocrinology/diabetes doctor),
      according to a standardized preset flowchart.

      This means that the doctors in this study will be controlling the subject's blood sugar and
      blood pressure values closely and may be changing the subject's blood pressure and/or your
      blood sugar medications during this study depending on what the subject's blood sugar and
      blood pressure values are. The subject will be instructed not to have their own primary care
      doctor or diabetes doctor adjust their diabetes or blood pressure as both will be managed
      closely by the study doctors during the entire 6 month study period. The subject doctors'
      will be sent a letter notifying of the subject's participation in the study and be instructed
      not to adjust any of the subject's blood sugar or blood pressure medications during the
      entire 6 month study as it will be done closely by the study doctors, as clinically
      indicated. The subject's doctor will be sent letters after each study visit detailing what
      changes were done, if any, to your blood sugar and blood pressure medication regimen. The
      subject will be interviewed on the phone every 2 weeks to assess for any medication adverse
      reactions and treatment compliance.
    

Intervention name(s): Vitamin D; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.; The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: uncontrolled diabetes; vitamin D deficiency