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

NCT ID: NCT01425424

Last Updated: 2015-12-18

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2013-12-31

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.

Conditions

Prediabetes; Prehypertension

Keywords

Vitamin D; Prediabetes; Prehypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Fasting glucose (blood sugar)

This group is associated with a diagnosis of prediabetes

Group Type: EXPERIMENTAL

Vitamin D supplementation

Intervention Type: OTHER

Vitamin D

Resting Blood pressure

This group is associated with a diagnosis of prehypertension.

Group Type: EXPERIMENTAL

Vitamin D supplementation

Intervention Type: OTHER

Vitamin D

Fasting Glucose & Resting Blood Pressure

coexisting prediabetes and prehypertension

Group Type: EXPERIMENTAL

Vitamin D supplementation

Intervention Type: OTHER

Vitamin D

Interventions

Vitamin D supplementation

Vitamin D

Intervention Type: OTHER

Other Intervention Names

Vitamin D

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pennington Biomedical Research Center

OTHER

Sponsor Role: lead

Responsible Party

Frank Greenway

Princiapal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alok Gupta, MD, AAFP, FASH

Role: PRINCIPAL_INVESTIGATOR

Pennington Biomedical Research Center

Locations

Physicians Care Center

Baton Rouge, Louisiana, United States

Bradley L. Meek, MD, Internal Medicine at Hennessy

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 (Second Location)

Durham, North Carolina, United States

Amarica Family Practice Office (First Location)

Roxboro, North Carolina, United States

Countries

United States

Other Identifiers

PBRC 10036

Identifier Type: -

Identifier Source: org_study_id