Title
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
Phase
N/ALead Sponsor
NBTY, Inc.Study Type
InterventionalStatus
Completed No Results PostedIndication/Condition
ToleranceIntervention/Treatment
vitamin c ...Study Participants
50The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.
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
