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Completed

NCT Number: NCT01873820

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KGK Synergize, Inc

London, Ontario, N6A 5R8, Canada

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Calcium ascorbate

Dietary Supplement

ascorbic acid

Dietary Supplement

Primary outcomes

  1. Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days

    Time frame: 0, 5 and 10 days

Sponsors and collaborators

Lead sponsor

NBTY, Inc.

Industry

Collaborators

  • KGK Science Inc.
  • Moyad, Mark MD MPH

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
First posted
Jun 10, 2013
Registry last updated
Jun 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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