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

June 6, 2013 updated by: NBTY, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5R8
        • KGK Synergize, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcium ascorbate -> ascorbic acid
Dietary supplement: Calcium ascorbate
Dietary supplement: Ascorbic acid
Experimental: Ascorbic acid -> calcium ascorbate
Dietary supplement: Calcium ascorbate
Dietary supplement: Ascorbic acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
Time Frame: 0, 5 and 10 days
0, 5 and 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NBTY, Inc.

Collaborators

KGK Science Inc.
Moyad, Mark MD MPH

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

May 14, 2013

First Submitted That Met QC Criteria

June 6, 2013

First Posted (Estimate)

June 10, 2013

Study Record Updates

Last Update Posted (Estimate)

June 10, 2013

Last Update Submitted That Met QC Criteria

June 6, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07EAHT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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