Effect of Vitamin D Supplementation on Hemoglobin A1c
| Status: | Completed |
|---|---|
| Conditions: | Other Indications, Gastrointestinal, Diabetes |
| Therapuetic Areas: | Endocrinology, Gastroenterology, Other |
| Healthy: | No |
| Age Range: | 34 - 69 |
| Updated: | 4/13/2015 |
| Start Date: | March 2011 |
| End Date: | June 2012 |
| Contact: | Prabhat K Pokhrel, MD |
| Email: | ppokhrel@genesys.org |
| Phone: | 810-715-4300 |
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?
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.
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.
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.
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.
Inclusion Criteria:
- Type 2 diabetes mellitus
- Hgb A1c greater then 7.0
- Adults aged 34 to 69 years.
Exclusion Criteria:
- 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
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