NCT01425424

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2012

Geographic Reach
1 country

7 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 30, 2011

Completed
7 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

December 18, 2015

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

August 10, 2011

Last Update Submit

December 17, 2015

Conditions

PrediabetesPrehypertension

Keywords

Vitamin DPrediabetesPrehypertension

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (3)

Fasting glucose (blood sugar)

EXPERIMENTAL

This group is associated with a diagnosis of prediabetes

Other: Vitamin D supplementation

Resting Blood pressure

EXPERIMENTAL

This group is associated with a diagnosis of prehypertension.

Other: Vitamin D supplementation

Fasting Glucose & Resting Blood Pressure

EXPERIMENTAL

coexisting prediabetes and prehypertension

Other: Vitamin D supplementation

Interventions

Vitamin D supplementationOTHER

Vitamin D

Also known as: Vitamin D
Fasting Glucose & Resting Blood PressureFasting glucose (blood sugar)Resting Blood pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Women who are pregnant or nursing
  • Anyone with chronic medical conditions requiring regular intake of any prescription medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Physicians Care Center

Baton Rouge, Louisiana, 70806, United States

Location

Bradley L. Meek, MD, Internal Medicine at Hennessy

Baton Rouge, Louisiana, 70808, United States

Location

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Metabolic Clinic Women's Hospital

Baton Rouge, Louisiana, 70809, United States

Location

Egan Wellness Clinic/AntiAging & Skin Care Spa

Covington, Louisiana, 70433, United States

Location

Amarica Family Practice Office (Second Location)

Durham, North Carolina, 27704, United States

Location

Amarica Family Practice Office (First Location)

Roxboro, North Carolina, 27573, United States

Location

MeSH Terms

Conditions

Prediabetic StatePrehypertension

Interventions

Vitamin D

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Alok Gupta, MD, AAFP, FASH

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Princiapal Investigator

Study Record Dates

First Submitted

August 10, 2011

First Posted

August 30, 2011

Study Start

April 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

December 18, 2015

Record last verified: 2015-12

Locations

US(7)