Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
Primary Purpose
Tolerance
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Calcium ascorbate
Ascorbic acid
Sponsored by
About this trial
This is an interventional basic science trial for Tolerance focused on measuring Vitamin C, calcium ascorbate, ascorbic acid
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
Sites / Locations
- KGK Synergize, Inc
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Calcium ascorbate -> ascorbic acid
Ascorbic acid -> calcium ascorbate
Arm Description
Outcomes
Primary Outcome Measures
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
Secondary Outcome Measures
Full Information
NCT ID
NCT01873820
First Posted
May 14, 2013
Last Updated
June 6, 2013
Sponsor
NBTY, Inc.
Collaborators
KGK Science Inc., Moyad, Mark MD MPH
1. Study Identification
Unique Protocol Identification Number
NCT01873820
Brief Title
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
Official Title
A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
Study Type
Interventional
2. Study Status
Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NBTY, Inc.
Collaborators
KGK Science Inc., Moyad, Mark MD MPH
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tolerance
Keywords
Vitamin C, calcium ascorbate, ascorbic acid
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Calcium ascorbate -> ascorbic acid
Arm Type
Experimental
Arm Title
Ascorbic acid -> calcium ascorbate
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium ascorbate
Intervention Type
Dietary Supplement
Intervention Name(s)
Ascorbic acid
Primary Outcome Measure Information:
Title
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
Time Frame
0, 5 and 10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Crowley, MD
Organizational Affiliation
KGK Science Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
KGK Synergize, Inc
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
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