Comparative Bioavailability of Two Forms of Vitamin C

NCT ID: NCT01852903

Last Updated: 2013-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Bioavailability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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calcium ascorbate

Group Type EXPERIMENTAL

calcium ascorbate

Intervention Type DIETARY_SUPPLEMENT

ascorbic acid

Group Type ACTIVE_COMPARATOR

ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

Interventions

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calcium ascorbate

Intervention Type DIETARY_SUPPLEMENT

ascorbic acid

Intervention Type DIETARY_SUPPLEMENT

placebo

Intervention Type OTHER

Other Intervention Names

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vitamin C vitamin C

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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KGK Science Inc.

INDUSTRY

Sponsor Role collaborator

Moyad, Mark MD MPH

UNKNOWN

Sponsor Role collaborator

NBTY, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dale R Wilson, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science Inc.

Locations

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KGK Synergize Inc

London, Ontario, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 27512620 (View on PubMed)

Other Identifiers

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11CIHE

Identifier Type: -

Identifier Source: org_study_id

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