Comparative Bioavailability of Two Forms of Vitamin C

Bioavailability Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01852903
• Other study ID #: 11CIHE
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: May 9, 2013
• Start date: May 2011

Study information

• Verified date: May 2013
• Source: NBTY, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. primary completion date: July 2011
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability

Intervention

Dietary Supplement:
• calcium ascorbate

• ascorbic acid

Other:
• placebo

Locations

Country	Name	City	State
Canada	KGK Synergize Inc	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
NBTY, Inc.	KGK Synergize Inc., Moyad, Mark MD MPH

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma and leukocyte vitamin C concentration		0, 2, 4, 8 and 24 hours	No