Status:
COMPLETED
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
Lead Sponsor:
NBTY, Inc.
Collaborating Sponsors:
KGK Science Inc.
Moyad, Mark MD MPH
Conditions:
Tolerance
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.
Eligibility Criteria
Inclusion
- Healthy as determined by laboratory results and medical history
- Females not of child bearing potential
- Self-reported sensitivity to acidic foods
- Agrees to consume a low vitamin C diet
Exclusion
- Pregnant, breastfeeding, or planning to become pregnant during the trial
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01873820
Start Date
March 1 2008
Last Update
June 10 2013
Active Locations (1)
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1
KGK Synergize, Inc
London, Ontario, Canada, N6A 5R8