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

Not Applicable

Terminated

• Conditions: Prehypertension; Prediabetes
• Interventions: Other: Vitamin D supplementation

• Registration Number: NCT01425424
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-08-10
• Study First Submitted QC: 2011-08-29
• Study First Posted: 2011-08-30
• Study Start: 2012-04
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resting Blood pressure	Vitamin D supplementation	This group is associated with a diagnosis of prehypertension.
Fasting glucose (blood sugar)	Vitamin D supplementation	This group is associated with a diagnosis of prediabetes
Fasting Glucose & Resting Blood Pressure	Vitamin D supplementation	coexisting prediabetes and prehypertension

Primary Outcome Measures

Name	Time	Method
Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention	8 weeks	An analysis of the fasting glucose, resting blood pressure and/or both will be performed. A blood test to check your vitamin D level and routine chemistry including a complete lipid profile, liver and kidney function will also be done. At the end of 8 weeks fasting blood glucose and resting blood pressure will be measured. If the desired results (fasting glucose less than 100 mg/dL and/or resting blood pressure less than 120/80 mm Hg) are not seen these measures will be repeated at 16 weeks. You will be asked to stay in the study for up to 5 years.

Trial Locations

Locations (7)

Bradley L. Meek, MD, Internal Medicine at Hennessy; 🇺🇸 Baton Rouge, Louisiana, United States

Physicians Care Center; 🇺🇸 Baton Rouge, Louisiana, United States

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States

Metabolic Clinic Women's Hospital; 🇺🇸 Baton Rouge, Louisiana, United States

Egan Wellness Clinic/AntiAging & Skin Care Spa; 🇺🇸 Covington, Louisiana, United States

Amarica Family Practice Office (First Location); 🇺🇸 Roxboro, North Carolina, United States

Amarica Family Practice Office (Second Location); 🇺🇸 Durham, North Carolina, United States