Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
NCT ID: NCT01873820
Last Updated: 2013-06-10
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
50 participants
INTERVENTIONAL
2008-03-31
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 -> ascorbic acid
Calcium ascorbate
Ascorbic acid
Ascorbic acid -> calcium ascorbate
Calcium ascorbate
Ascorbic acid
Interventions
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Calcium ascorbate
Ascorbic acid
Eligibility Criteria
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Inclusion Criteria
* Females not of child bearing potential
* Self-reported sensitivity to acidic foods
* Agrees to consume a low vitamin C diet
Exclusion Criteria
* Use of medications known to interact with vitamin C or cause epigastric effects
* Use of supplements containing containing vitamin C
* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
* Use of antacids and/or acid suppressors within 4 weeks of randomization
* History of irritable bowel syndrome and related disorders
* Alcohol use \> 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year
* History of cardiac disease within the past 6 months
* History of or current diagnosis of cancer
* Uncontrolled hypertension
* Unstable renal and/or liver disease
* History of kidney stones
* Unstable psychiatric disorder
* History of or current immunocompromise
* History of hemoglobinopathies
* Participation in another clinical research trial \<30 days
* Abnormal liver function
* Serum creatinine \> 1.5 x upper limit of normal (ULN)
* Anemia of any etiology
* Uncontrolled and/or untreated thyroid disorder
* BMI ≥ 35 kg/m2
* Unstable medications \<30 days
* Allergy or sensitivity to test article ingredients
* Cognitively impaired and/or unable to give informed consent
18 Years
75 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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David Crowley, MD
Role: PRINCIPAL_INVESTIGATOR
KGK Science Inc.
Locations
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KGK Synergize, Inc
London, Ontario, Canada
Countries
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Other Identifiers
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07EAHT
Identifier Type: -
Identifier Source: org_study_id
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