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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01873820
Recruitment Status : Completed
First Posted : June 10, 2013
Last Update Posted : June 10, 2013
Sponsor:
Collaborators:
KGK Science Inc.
Moyad, Mark MD MPH
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Tolerance Dietary Supplement: Calcium ascorbate Dietary Supplement: Ascorbic acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
Study Start Date : March 2008
Actual Primary Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin C

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



Primary Outcome Measures :
  1. Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days [ Time Frame: 0, 5 and 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873820


Locations
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Canada, Ontario
KGK Synergize, Inc
London, Ontario, Canada, N6A 5R8
Sponsors and Collaborators
NBTY, Inc.
KGK Science Inc.
Moyad, Mark MD MPH
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.

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Responsible Party: NBTY, Inc.
ClinicalTrials.gov Identifier: NCT01873820     History of Changes
Other Study ID Numbers: 07EAHT
First Posted: June 10, 2013    Key Record Dates
Last Update Posted: June 10, 2013
Last Verified: June 2013

Keywords provided by NBTY, Inc.:
Vitamin C
calcium ascorbate
ascorbic acid

Additional relevant MeSH terms:
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Vitamins
Ascorbic Acid
Calcium ascorbate
Calcium
Calcium, Dietary
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents