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Comparative Bioavailability of Two Forms of Vitamin C

Information source: NBTY, Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bioavailability

Intervention: calcium ascorbate (Dietary Supplement); ascorbic acid (Dietary Supplement); placebo (Other)

Phase: N/A

Status: Completed

Sponsored by: NBTY, Inc.

Official(s) and/or principal investigator(s):
Dale R Wilson, MD, Principal Investigator, Affiliation: KGK Synergize Inc.

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.

Clinical Details

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.

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

Primary outcome: Plasma and leukocyte vitamin C concentration

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

KGK Synergize Inc, London, Ontario N6A 5R8, Canada
Additional Information

Starting date: May 2011
Last updated: May 9, 2013

Page last updated: August 20, 2015

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