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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.

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.

Condition or disease Intervention/treatment Phase
Bioavailability Dietary Supplement: calcium ascorbate Dietary Supplement: ascorbic acid Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
Study Start Date : May 2011
Actual Primary Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

Arm Intervention/treatment
Experimental: calcium ascorbate Dietary Supplement: calcium ascorbate
Other Name: vitamin C

Active Comparator: ascorbic acid Dietary Supplement: ascorbic acid
Other Name: vitamin C

Placebo Comparator: placebo Other: placebo



Primary Outcome Measures :
  1. Plasma and leukocyte vitamin C concentration [ Time Frame: 0, 2, 4, 8 and 24 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01852903


Locations
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Canada, Ontario
KGK Synergize Inc
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
NBTY, Inc.
KGK Science Inc.
Moyad, Mark MD MPH
Investigators
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Principal Investigator: Dale R Wilson, MD KGK Science Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NBTY, Inc.
ClinicalTrials.gov Identifier: NCT01852903    
Other Study ID Numbers: 11CIHE
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by NBTY, Inc.:
vitamin C
calcium ascorbate
ascorbic acid
bioavailability
Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Calcium ascorbate
Calcium
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents