Comparative Bioavailability of Two Forms of Vitamin C
A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.
1 other identifier
interventional
40
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 9, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedMay 14, 2013
May 1, 2013
2 months
May 9, 2013
May 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma and leukocyte vitamin C concentration
0, 2, 4, 8 and 24 hours
Study Arms (3)
calcium ascorbate
EXPERIMENTALascorbic acid
ACTIVE COMPARATORplacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NBTY, Inc.lead
- KGK Science Inc.collaborator
- Moyad, Mark MD MPHcollaborator
Study Sites (1)
KGK Synergize Inc
London, Ontario, N6A 5R8, Canada
Related Publications (1)
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.
PMID: 27512620DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dale R Wilson, MD
KGK Science Inc.
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 9, 2013
First Posted
May 14, 2013
Study Start
May 1, 2011
Primary Completion
July 1, 2011
Last Updated
May 14, 2013
Record last verified: 2013-05