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

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.

Study Overview

• Status: Terminated
• Conditions: Prehypertension; Prediabetes
• Intervention / Treatment: Other: Vitamin D supplementation

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center
    • Baton Rouge, Louisiana, United States, 70806
      • Physicians Care Center
    • Baton Rouge, Louisiana, United States, 70808
      • Bradley L. Meek, MD, Internal Medicine at Hennessy
    • Baton Rouge, Louisiana, United States, 70809
      • Metabolic Clinic Women's Hospital
    • Covington, Louisiana, United States, 70433
      • Egan Wellness Clinic/AntiAging & Skin Care Spa
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Amarica Family Practice Office (Second Location)
    • Roxboro, North Carolina, United States, 27573
      • Amarica Family Practice Office (First Location)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fasting glucose (blood sugar); This group is associated with a diagnosis of prediabetes	Other: Vitamin D supplementation; Vitamin D; Other Names: Vitamin D
Experimental: Resting Blood pressure; This group is associated with a diagnosis of prehypertension.	Other: Vitamin D supplementation; Vitamin D; Other Names: Vitamin D
Experimental: Fasting Glucose & Resting Blood Pressure; coexisting prediabetes and prehypertension	Other: Vitamin D supplementation; Vitamin D; Other Names: Vitamin D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention	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.	8 weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Alok Gupta, MD, AAFP, FASH, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 10, 2011
• First Submitted That Met QC Criteria: August 29, 2011
• First Posted (Estimate): August 30, 2011

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: Vitamin D; Prediabetes; Prehypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Hyperglycemia; Prehypertension; Prediabetic State; Glucose Intolerance; Physiological Effects of Drugs; Micronutrients; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents; Vitamin D; Cholecalciferol; Vitamins; Ergocalciferols
• Other Study ID Numbers: PBRC 10036