Status:
COMPLETED
Comparative Bioavailability of Two Forms of Vitamin C
Lead Sponsor:
NBTY, Inc.
Collaborating Sponsors:
KGK Science Inc.
Moyad, Mark MD MPH
Conditions:
Bioavailability
Eligibility:
All Genders
18-60 years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01852903
Start Date
May 1 2011
Last Update
May 14 2013
Active Locations (1)
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1
KGK Synergize Inc
London, Ontario, Canada, N6A 5R8