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Comparative Bioavailability of Two Forms of Vitamin C

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01852903
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Sponsor:
Collaborators:
KGK Science Inc.
Moyad, Mark MD MPH
Information provided by (Responsible Party):
NBTY, Inc.

Tracking Information
First Submitted Date  ICMJE May 9, 2013
First Posted Date  ICMJE May 14, 2013
Last Update Posted Date May 14, 2013
Study Start Date  ICMJE May 2011
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2013)
Plasma and leukocyte vitamin C concentration [ Time Frame: 0, 2, 4, 8 and 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Bioavailability of Two Forms of Vitamin C
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Bioavailability
Intervention  ICMJE
  • Dietary Supplement: calcium ascorbate
    Other Name: vitamin C
  • Dietary Supplement: ascorbic acid
    Other Name: vitamin C
  • Other: placebo
Study Arms  ICMJE
  • Experimental: calcium ascorbate
    Intervention: Dietary Supplement: calcium ascorbate
  • Active Comparator: ascorbic acid
    Intervention: Dietary Supplement: ascorbic acid
  • Placebo Comparator: placebo
    Intervention: Other: placebo
Publications * Mitmesser SH, Ye Q, Evans M, Combs M. Determination of plasma and leukocyte vitamin C concentrations in a randomized, double-blind, placebo-controlled trial with Ester-C(®). Springerplus. 2016 Jul 25;5(1):1161. doi: 10.1186/s40064-016-2605-7. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2013)
40
Original Actual Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Not Provided
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01852903
Other Study ID Numbers  ICMJE 11CIHE
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party NBTY, Inc.
Study Sponsor  ICMJE NBTY, Inc.
Collaborators  ICMJE
  • KGK Science Inc.
  • Moyad, Mark MD MPH
Investigators  ICMJE
Principal Investigator: Dale R Wilson, MD KGK Science Inc.
PRS Account NBTY, Inc.
Verification Date May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP