Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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calcium ascorbate
calcium ascorbate
ascorbic acid
ascorbic acid
placebo
placebo
Interventions
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calcium ascorbate
ascorbic acid
placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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KGK Science Inc.
INDUSTRY
Moyad, Mark MD MPH
UNKNOWN
NBTY, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Dale R Wilson, MD
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
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KGK Synergize Inc
London, Ontario, Canada
Countries
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References
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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((R)). Springerplus. 2016 Jul 25;5(1):1161. doi: 10.1186/s40064-016-2605-7. eCollection 2016.
Other Identifiers
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11CIHE
Identifier Type: -
Identifier Source: org_study_id
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