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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01873820

Enrollment

Registered

2013-06-10

Start date

2008-03-31

Completion date

Unknown

Last updated

2013-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tolerance

Keywords

Vitamin C, calcium ascorbate, ascorbic acid

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.

Interventions

DIETARY_SUPPLEMENTCalcium ascorbate

DIETARY_SUPPLEMENTAscorbic acid

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026