Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults

Not Applicable

Completed

• Conditions: Tolerance
• Interventions: Dietary Supplement: Calcium ascorbate; Dietary Supplement: Ascorbic acid

• Registration Number: NCT01873820
• Lead Sponsor: NBTY, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Primary Completion: 2008-06
• Study First Submitted: 2013-05-14
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-06
• Last Update Submitted: 2013-06-06
• Study First Posted: 2013-06-10
• Last Update Posted: 2013-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Ascorbic acid -> calcium ascorbate	Calcium ascorbate	-
Ascorbic acid -> calcium ascorbate	Ascorbic acid	-
Calcium ascorbate -> ascorbic acid	Calcium ascorbate	-
Calcium ascorbate -> ascorbic acid	Ascorbic acid	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days	0, 5 and 10 days

Trial Locations

Locations (1)

KGK Synergize, Inc; 🇨🇦 London, Ontario, Canada