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

Prediabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01425424
• Other study ID #: PBRC 10036
• Status: Terminated
• Phase: N/A
• First received: August 10, 2011
• Last updated: December 17, 2015
• Start date: April 2012
• Est. completion date: December 2013

Study information

• Verified date: December 2015
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Glucose Intolerance
• Prediabetes
• Prediabetic State
• Prehypertension

Intervention

Other:
• Vitamin D supplementation
Vitamin D

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No