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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
NBTY, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Tolerance focused on measuring Vitamin C, calcium ascorbate, ascorbic acid

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All Sexes

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

First Posted
May 14, 2013
Last Updated
June 6, 2013
Sponsor
NBTY, Inc.
Collaborators
KGK Science Inc., Moyad, Mark MD MPH
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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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