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

Tolerance Clinical Trial

Official title:

A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873820
• Other study ID #: 07EAHT
• Status: Completed
• Phase: N/A
• First received: May 14, 2013
• Last updated: June 6, 2013
• Start date: March 2008

Study information

• Verified date: June 2013
• Source: NBTY, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: June 2008
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Tolerance

Intervention

Dietary Supplement:
• Calcium ascorbate

• Ascorbic acid

Locations

Country	Name	City	State
Canada	KGK Synergize, Inc	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
NBTY, Inc.	KGK Synergize Inc., Moyad, Mark MD MPH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days		0, 5 and 10 days	Yes