BioavailabilityNCT01852903
Comparative Bioavailability of Two Forms of Vitamin C
A study testing calcium ascorbate and ascorbic acid in people with Bioavailability, run by NBTY, Inc. at 1 site in Canada.
Trial summary
The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bioavailability
- What is being tested?
- calcium ascorbate and ascorbic acid
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- May 2011to Jul 2011
- 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 60 years
- All sexes
- Adult
Who may be able to join
- Healthy as determined by laboratory results and medical history
- Females not of child bearing potential
- BMI 18-30 kg/m2
- Agrees to consume a low vitamin C diet
- Non-smoker or ex-smoker >1 year
Who cannot join
- Pregnant, breastfeeding, or planning to become pregnant during the trial
- Alcohol >2 drinks per day; alcohol or drug abuse within the past year
- Cardiac conditions
- Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
- History irritable bowel syndrome, malabsorption or significant GI disease
- History of kidney stones
Show all 24Show fewer
- Use of medications known to interact with vitamin C
- Use of supplements containing vitamin C
- Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications
- History of or current diagnosis of cancer
- Uncontrolled hypertension
- History of diabetes, renal disease and/or liver disease
- Unstable psychiatric disorder
- History of or current immunocompromise
- History of hemochromatosis or hemoglobinopathies
- Participation in a clinical research trial <30 days
- Use of acute medication w/in 72 hours of intervention
- Unstable medications <90 days
- Abnormal liver function
- Serum creatinine > 1.5 x upper limit of normal (ULN)
- Anemia of any etiology
- Blood donation w/in the last 2 months
- Allergy or sensitivity to test articles, foods or beverages provided during the study
- Cognitive impairment 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, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
The purpose of this study is to compare levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.
- Conditions
- Bioavailability
- Being tested
- calcium ascorbate, ascorbic acid, placebo
- Keywords
- vitamin C, calcium ascorbate, ascorbic acid, bioavailability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium ascorbateDietary supplement
Also called vitamin C
ascorbic acidDietary supplement
Also called vitamin C
placeboOther
| Study group | Role | What they receive |
|---|---|---|
| calcium ascorbate | Experimental | Not described Receives: Dietary Supplement: calcium ascorbate |
| ascorbic acid | Active comparator | Not described Receives: Dietary Supplement: ascorbic acid |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma and leukocyte vitamin C concentration
Measured: 0, 2, 4, 8 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2013 (estimated)
- Study startMay 2011
- Primary completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BioavailabilityStudies 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
- 40 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
- Dale R Wilson, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01852903
- Sponsor's protocol ID
- 11CIHE
- Status last verified
- May 2013
- First submitted
- 9 May 2013
- Last updated
- 14 May 2013
- Results posted
- No
Publications
Mitmesser SH, Ye Q, Evans M, Combs M. Determination of plasma and leukocyte vitamin C concentrations in a randomized, double-blind, placebo-controlled trial with Ester-C((R)). Springerplus. 2016 Jul 25;5(1):1161. doi: 10.1186/s40064-016-2605-7. eCollection 2016.
PubMed 27512620
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
- ClinicalTrials.gov ID
- NCT01852903
- Acronym / sponsor ID
- 11CIHE
- Conditions
- Bioavailability
- Keywords
- vitamin C, calcium ascorbate, ascorbic acid, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NBTY, Inc.Industry (pharma, biotech, devices)
- Collaborators
- KGK Science Inc., Moyad, Mark MD MPH
- Study start
- May 2011
- Primary completion
- Jul 2011 (actual)
- First posted
- 14 May 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 levels of vitamin C in the blood over the 24 hour period following a single 1000 mg dose of vitamin C from ascorbic acid, calcium ascorbate and placebo.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| calcium ascorbate | Experimental | Dietary Supplement: calcium ascorbate |
| ascorbic acid | Active comparator | Dietary Supplement: ascorbic acid |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy as determined by laboratory results and medical history
- Females not of child bearing potential
- BMI 18-30 kg/m2
- Agrees to consume a low vitamin C diet
- Non-smoker or ex-smoker >1 year
Key exclusion criteria (24 listed)
- Pregnant, breastfeeding, or planning to become pregnant during the trial
- Alcohol >2 drinks per day; alcohol or drug abuse within the past year
- Cardiac conditions
- Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months
- History irritable bowel syndrome, malabsorption or significant GI disease
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 ascorbateAlso: vitamin C | Dietary supplement | calcium ascorbate |
| ascorbic acidAlso: vitamin C | Dietary supplement | ascorbic acid |
| placebo | Other | placebo |
Primary outcome
Plasma and leukocyte vitamin C concentration
Time frame: 0, 2, 4, 8 and 24 hours
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 14 May 2013.
- Derived from this study: PubMed 27512620Mitmesser SH, Ye Q, Evans M, Combs M. Determination of plasma and leukocyte vitamin C concentrations in a randomized, double-blind, placebo-controlled trial with Ester-C((R)). Springerplus. 2016 Jul 25;5(1):1161. doi: 10.1186/s40064-016-2605-7. eCollection 2016.
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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.
Dale R Wilson, 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 Bioavailability, 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 5 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 14 May 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. Some participants in this study may receive a placebo. 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?
Plasma and leukocyte vitamin C concentration (time frame: 0, 2, 4, 8 and 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01852903, which also lists 1 linked publication.
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 14 May 2013.