NCT01873820

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
5 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
27 days until next milestone

First Posted

Study publicly available on registry

June 10, 2013

Completed
Last Updated

June 10, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

May 14, 2013

Last Update Submit

June 6, 2013

Conditions

Tolerance

Keywords

Vitamin Ccalcium ascorbateascorbic acid

Outcome Measures

Primary Outcomes (1)

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

    0, 5 and 10 days

Study Arms (2)

Calcium ascorbate -> ascorbic acid

EXPERIMENTAL
Dietary Supplement: Calcium ascorbateDietary Supplement: Ascorbic acid

Ascorbic acid -> calcium ascorbate

EXPERIMENTAL
Dietary Supplement: Calcium ascorbateDietary Supplement: Ascorbic acid

Interventions

Calcium ascorbateDIETARY_SUPPLEMENT
Ascorbic acid -> calcium ascorbateCalcium ascorbate -> ascorbic acid
Ascorbic acidDIETARY_SUPPLEMENT
Ascorbic acid -> calcium ascorbateCalcium ascorbate -> ascorbic acid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KGK Synergize, Inc

London, Ontario, N6A 5R8, Canada

Location

MeSH Terms

Interventions

calcium ascorbateAscorbic Acid

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydrates

Study Officials

  • David Crowley, MD

    KGK Science Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

June 10, 2013

Study Start

March 1, 2008

Primary Completion

June 1, 2008

Last Updated

June 10, 2013

Record last verified: 2013-06

Locations

CA(1)