Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study

Pennington Biomedical Research Center

Status: Terminated

Conditions: Prediabetes; Prehypertension

Treatments: Other: Vitamin D supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT01425424

PBRC 10036

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Fasting glucose (blood sugar)

Experimental group

Description:

This group is associated with a diagnosis of prediabetes

Treatment:

Other: Vitamin D supplementation

Resting Blood pressure

Experimental group

Description:

This group is associated with a diagnosis of prehypertension.

Treatment:

Other: Vitamin D supplementation

Fasting Glucose & Resting Blood Pressure

Experimental group

Description:

coexisting prediabetes and prehypertension

Treatment:

Other: Vitamin D supplementation