Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study
| Status: | Terminated |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Endocrine, Diabetes |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | April 2012 |
| End Date: | December 2013 |
This randomized, double-blind, placebo-controlled, multi-site study is to reverse modest
elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension)
or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D.
This may reduce the chances of developing diabetes or high blood pressure or both later in
life.
elevations of fasting blood sugar (prediabetes) and resting blood pressure(Prehypertension)
or both co existing prediabetes and prehypertension by increasing blood levels of vitamin D.
This may reduce the chances of developing diabetes or high blood pressure or both later in
life.
Study visits will measure temperature, fasting glucose, resting blood pressure, respiratory
rate, height, weight and waist circumference. A brief medical History will be taken,
followed by an abbreviated physical exam. A blood test to check your vitamin D level and
routine chemistry including a complete lipid profile, liver and kidney function will be
completed.
Based on your fasting glucose and/or resting blood pressure you will be in one of the three
arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and
prehypertension (arm 3). After determining the arm of the study you are in, you will be
randomly assigned to receive either a placebo or vitamin D supplementation.
If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary
outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until
you are in the study up to 5 years. If you are in the second arm with prehypertension
(resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in
resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up
to 5 years. If you are in third arm with prediabetes and prehypertension, both these
measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up
to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks
(and periodically as necessary) during the study.
Other measures will be taken as are routine in your doctor's office.
rate, height, weight and waist circumference. A brief medical History will be taken,
followed by an abbreviated physical exam. A blood test to check your vitamin D level and
routine chemistry including a complete lipid profile, liver and kidney function will be
completed.
Based on your fasting glucose and/or resting blood pressure you will be in one of the three
arms: prediabetes (arm 1), prehypertension (arm 2) or co-existing prediabetes and
prehypertension (arm 3). After determining the arm of the study you are in, you will be
randomly assigned to receive either a placebo or vitamin D supplementation.
If you are in the first arm with prediabetes (fasting glucose 100-125 mg/dL), the primary
outcome measure will change in fasting glucose at 8 weeks, 16 weeks and every 3 months until
you are in the study up to 5 years. If you are in the second arm with prehypertension
(resting blood pressure 120-139/80-89 mm Hg), the primary outcome measure will change in
resting blood pressure at 8 weeks, 16 weeks and every 3 months until you are in the study up
to 5 years. If you are in third arm with prediabetes and prehypertension, both these
measures will be taken at 8 weeks, 16 weeks and every 3 months until you are in the study up
to 5 years. A repeat blood test to check vitamin D levels will be done at 8 and 16 weeks
(and periodically as necessary) during the study.
Other measures will be taken as are routine in your doctor's office.
Inclusion Criteria:
- Healthy Male or Female 18 years or older presenting to The America Family Practice,
Physicians Care Center offices or Egan Wellness Clinic/Anti-Aging & Skin Care Spa.
- Agreeable to treatment with placebo or vitamin D 1000IU twice a day with food.
Exclusion Criteria:
- Women who are pregnant or nursing
- Anyone with chronic medical conditions requiring regular intake of any prescription
medications.
We found this trial at
7
sites
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