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临床试验/NCT01354262
NCT01354262已完成2 期

Does Vitamin D Supplement Alter Serum Level of Glycosylated Hemoglobin in Adult Patients Between 34-74 Years With Type 2 Diabetes Mellitus and Vitamin D Deficiency?

Ascension Health2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
150
试验地点
2
主要终点
Change in serum levels of Hemoglobin A1c.

研究概览

简要总结

This is a prospective, randomized, non-blinded interventional study that will investigate the effect of a vitamin D supplement on HbA1c in patients with uncontrolled type 2 diabetes mellitus (DM) and vitamin D deficiency. The goal is to investigate whether correcting vitamin D deficiency will alter the HbA1c level in patients with type 2 DM and lower than normal vitamin D level. My hypothesis is that correcting vitamin D deficiency decreases HbA1c levels in patients with type 2 DM and vitamin D deficiency.

详细描述

The total number of study subjects expected to be enrolled in this study is about 150. Study subjects included in this study will be men and women between 34-69 years of age who have been diagnosed with type 2 DM based on at least one of the American Diabetic Association criteria. These criteria are 1) fasting blood glucose higher than 125 mg/dL once with symptoms of diabetes (increased urination, increased appetite, increased thirst) or two times without symptoms; 2) random blood glucose more than 200 mg/dL once with symptoms or two times without symptoms of diabetes; 3) two hour glucose tolerance test more than 200 mg/dL once with symptoms or two times without symptoms; or 4) a random glycosylated hemoglobin more than 6.5 % two times. The age group for this research was selected based on the review of the literature on diabetes and vitamin D. Patients with known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness, history of serum creatinine more than 2.0 mg/dL, vitamin D supplement more than 200 IU/day, inflammatory bowel disease and history of hypercalcemia and kidney stones will be excluded from this study. For this project, vitamin D deficiency is defined as serum vitamin D level lower than 30 ng/mL and uncontrolled diabetes is defined as HbA1C level above 7.0. Although there is more than one recommended normal level of vit. D in the blood, most experts agree that the optimum serum level of vitamin D should be above 30 ng/mL. All subjects will be receiving standard of care for DM offered to them by his or her physician.

The investigators will investigate if different but fixed doses of vitamin D (600 IU a day vs 50,000 IU once every other week) when given to patients with type 2 DM and vitamin D deficiency have different effects on HbA1c level at the end of 24 weeks. A baseline blood draw, and fasting blood draws will be taken at 12 and 24 weeks for blood sugar levels, Vit D levels, and HgbA1c. Subjects with vitamin D deficiency will be randomly assigned to either group 1 or 2 and will be supplemented with either 600 IU of vitamin D/day (Group 1) or 50,000 IU of vitamin D every 2 weeks for 24 weeks (Groups 2). Patients who are not vitamin D deficient will be followed as the control group (Group 3) and will not be given any vitamin D supplement.Research subjects will be advised not to take any vitamin D or multivitamin while participating in this study. Subjects will be given 100 tablets of 600 IU of vitamin D in a bottle if they belong to Group 1. If they have been advised to take vitamin D 50,000 IU once every 14 days (Group 2), they will be given altogether 13 tablets of 50,000 of vitamin D each in a separate brown envelope with date written on the envelop and subjects will be asked to take vitamin D only on the date written on the envelop.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
34 Years 至 69 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Type 2 diabetes mellitus
  • Hgb A1c greater then 7.0
  • Adults aged 34 to 69 years.

排除标准

  • known primary hyperparathyroidism, sarcoidosis, tuberculosis, cancer, potential terminal illness,
  • history of serum creatinine more than 2.0 mg/dL,
  • vitamin D supplement more than 200 IU/day
  • history of inflammatory bowel disease, hypercalcemia or kidney stones

结局指标

主要结局

Change in serum levels of Hemoglobin A1c.

时间窗: Change from baseline assessed at 12 wk and 24 wk.

Serum levels of hemoglobin A1c will be tested in the laboratory from blood draws conducted at baseline and at 12 and 24 weeks from a fasting blood sample.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Principal Investigator
主要研究者

Prabhat Pokhrel

Physician

Ascension Health

研究点 (2)

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