Clinical trial NCT01425424: Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study
Official title: Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prediabetes
Prehypertension
Keywords: Vitamin D
Prediabetes
Prehypertension
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2011-08-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Physicians Care Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Bradley L. Meek, MD, Internal Medicine at Hennessy
state: Louisiana
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Baton Rouge
country: United States
facility: Metabolic Clinic Women's Hospital
state: Louisiana
city: Covington
country: United States
facility: Egan Wellness Clinic/AntiAging & Skin Care Spa
state: Louisiana
city: Durham
country: United States
facility: Amarica Family Practice Office (Second Location)
state: North Carolina
city: Roxboro
country: United States
facility: Amarica Family Practice Office (First Location)
state: North Carolina
Study officials:
affiliation: Pennington Biomedical Research Center
name: Alok Gupta, MD, AAFP, FASH
role: PRINCIPAL_INVESTIGATOR
References: