ToleranceNCT01873820
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
A study testing Calcium ascorbate and Ascorbic acid in people with Tolerance, run by NBTY, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tolerance
- What is being tested?
- Calcium ascorbate and Ascorbic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jun 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tolerance
- Being tested
- Calcium ascorbate, Ascorbic acid
- Keywords
- Vitamin C, calcium ascorbate, ascorbic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium ascorbateDietary supplement
Ascorbic acidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Calcium ascorbate -> ascorbic acid | Experimental | Not described Receives: Dietary Supplement: Calcium ascorbate; Dietary Supplement: Ascorbic acid |
| Ascorbic acid -> calcium ascorbate | Experimental | Not described Receives: Dietary Supplement: Calcium ascorbate; Dietary Supplement: Ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
Measured: 0, 5 and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2013 (estimated)
- Study startMar 2008
- Primary completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ToleranceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- NBTY, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc., Moyad, Mark MD MPH
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01873820
- Sponsor's protocol ID
- 07EAHT
- Status last verified
- Jun 2013
- First submitted
- 14 May 2013
- Last updated
- 10 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults
- ClinicalTrials.gov ID
- NCT01873820
- Acronym / sponsor ID
- 07EAHT
- Conditions
- Tolerance
- Keywords
- Vitamin C, calcium ascorbate, ascorbic acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- NBTY, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc., Moyad, Mark MD MPH
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- First posted
- 10 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Calcium ascorbate -> ascorbic acid | Experimental | Dietary Supplement: Calcium ascorbate, Dietary Supplement: Ascorbic acid |
| Ascorbic acid -> calcium ascorbate | Experimental | Dietary Supplement: Calcium ascorbate, Dietary Supplement: Ascorbic acid |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium ascorbate | Dietary supplement | Ascorbic acid -> calcium ascorbate, Calcium ascorbate -> ascorbic acid |
| Ascorbic acid | Dietary supplement | Ascorbic acid -> calcium ascorbate, Calcium ascorbate -> ascorbic acid |
Primary outcome
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days
Time frame: 0, 5 and 10 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2013.
Related trials for Tolerance
Enrolling by invitationEarly Phase 1
Truway Diagnostic Tools in Primary Care
Chronic Disease, Type 2 Diabetes Mellitus (T2DM), Obesity, Overweight
RecruitingObservational study
Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.
Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application
Not yet recruiting
A Crossover Study Evaluating the Postprandial Glycemic Response of Three Sweeteners in a Mixed Meal Setting
Postprandial Glucose, GI Tolerance
RecruitingEarly Phase 1
Addition of Venetoclax to Combined Hematopoietic Stem Cell and Kidney Transplantation
Kidney Failure Chronic, Stem Cell Transplant
Active, not recruitingObservational study
Effects of External Upper Limb Loading on Gait and Trunk Muscle Activity in Cardiac Rehabilitation Patients
Cardiovascular Diseases, Cardiac Rehabilitation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium ascorbate and Ascorbic acid in people with Tolerance, run by NBTY, Inc. at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days (time frame: 0, 5 and 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2013; AzTrials last refreshed its copy on 7 Nov 2026.