Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT01852903
Eligibility 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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01852903
Study Brief:
Protocol Section:
NCT01852903