Comparative Bioavailability of Two Forms of Vitamin C

May 9, 2013 updated by: NBTY, Inc.

A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.

The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy as determined by laboratory results and medical history
  • Females not of child bearing potential
  • BMI 18-30 kg/m2
  • Agrees to consume a low vitamin C diet
  • Non-smoker or ex-smoker >1 year

Exclusion Criteria:

  • Pregnant, breastfeeding, or planning to become pregnant during the trial
  • Alcohol >2 drinks per day; alcohol or drug abuse within the past year
  • Cardiac conditions
  • Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
  • History irritable bowel syndrome, malabsorption or significant GI disease
  • History of kidney stones
  • Use of medications known to interact with vitamin C
  • Use of supplements containing vitamin C
  • Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
  • History of or current diagnosis of cancer
  • Uncontrolled hypertension
  • History of diabetes, renal disease and/or liver disease
  • Unstable psychiatric disorder
  • History of or current immunocompromise
  • History of hemochromatosis or hemoglobinopathies
  • Participation in a clinical research trial <30 days
  • Use of acute medication w/in 72 hours of intervention
  • Unstable medications <90 days
  • Abnormal liver function
  • Serum creatinine > 1.5 x upper limit of normal (ULN)
  • Anemia of any etiology
  • Blood donation w/in the last 2 months
  • Allergy or sensitivity to test articles, foods or beverages provided during the study
  • Cognitive impairment and/or unable to give informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Other: placebo
Experimental: calcium ascorbate
Dietary supplement: calcium ascorbate
Other Names:
  • vitamin C
Active Comparator: ascorbic acid
Dietary supplement: ascorbic acid
Other Names:
  • vitamin C

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Plasma and leukocyte vitamin C concentration
Time Frame: 0, 2, 4, 8 and 24 hours
0, 2, 4, 8 and 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NBTY, Inc.

Collaborators

KGK Science Inc.
Moyad, Mark MD MPH

Investigators

  • Principal Investigator: Dale R Wilson, MD, KGK Science Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 9, 2013

First Posted (Estimate)

May 14, 2013

Study Record Updates

Last Update Posted (Estimate)

May 14, 2013

Last Update Submitted That Met QC Criteria

May 9, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11CIHE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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