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:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT01873820
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01873820
Study Brief:
Protocol Section:
NCT01873820