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

This study has been terminated.
(The PI was leaving Pennington)
Sponsor:
Information provided by (Responsible Party):
Frank Greenway, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01425424
First received: August 10, 2011
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Prediabetes
Prehypertension
Other: Vitamin D supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Prediabetes, Prehypertension and Vitamin D Supplementation - A Practice Based Clinical Intervention Pilot Study

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Prediabetes, Prehypertension and Vitamin D supplementation- A practice based clinical intervention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 18
Study Start Date: April 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fasting glucose (blood sugar)
This group is associated with a diagnosis of prediabetes
Other: Vitamin D supplementation
Vitamin D
Other Name: Vitamin D
Experimental: Resting Blood pressure
This group is associated with a diagnosis of prehypertension.
Other: Vitamin D supplementation
Vitamin D
Other Name: Vitamin D
Experimental: Fasting Glucose & Resting Blood Pressure
coexisting prediabetes and prehypertension
Other: Vitamin D supplementation
Vitamin D
Other Name: Vitamin D

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01425424

Locations
United States, Louisiana
Physicians Care Center
Baton Rouge, Louisiana, United States, 70806
Metabolic Clinic Women's Hospital
Baton Rouge, Louisiana, United States, 70809
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Bradley L. Meek, MD, Internal Medicine at Hennessy
Baton Rouge, Louisiana, United States, 70808
Egan Wellness Clinic/AntiAging & Skin Care Spa
Covington, Louisiana, United States, 70433
United States, North Carolina
Amarica Family Practice Office (Second Location)
Durham, North Carolina, United States, 27704
Amarica Family Practice Office (First Location)
Roxboro, North Carolina, United States, 27573
Sponsors and Collaborators
Pennington Biomedical Research Center
Investigators
Principal Investigator: Alok Gupta, MD, AAFP, FASH Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Frank Greenway, Princiapal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01425424     History of Changes
Other Study ID Numbers: PBRC10036
Study First Received: August 10, 2011
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Vitamin D
Prediabetes
Prehypertension

Additional relevant MeSH terms:
Glucose Intolerance
Prediabetic State
Prehypertension
Hyperglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamin D
Ergocalciferols
Vitamins
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 28, 2014