Ignite Creation Date:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2026-02-22 @ 4:54 PM
Study NCT ID:
NCT01852903
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2013-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Bioavailability of Two Forms of Vitamin C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C069207', 'term': 'calcium ascorbate'}, {'id': 'D001205', 'term': 'Ascorbic Acid'}], 'ancestors': [{'id': 'D013400', 'term': 'Sugar Acids'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006880', 'term': 'Hydroxy Acids'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-05', 'lastUpdateSubmitDate': '2013-05-09', 'studyFirstSubmitDate': '2013-05-09', 'studyFirstSubmitQcDate': '2013-05-09', 'lastUpdatePostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma and leukocyte vitamin C concentration', 'timeFrame': '0, 2, 4, 8 and 24 hours'}]}, 'conditionsModule': {'keywords': ['vitamin C', 'calcium ascorbate', 'ascorbic acid', 'bioavailability'], 'conditions': ['Bioavailability']}, 'referencesModule': {'references': [{'pmid': '27512620', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy as determined by laboratory results and medical history\n* Females not of child bearing potential\n* BMI 18-30 kg/m2\n* Agrees to consume a low vitamin C diet\n* Non-smoker or ex-smoker \\>1 year\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning to become pregnant during the trial\n* Alcohol \\>2 drinks per day; alcohol or drug abuse within the past year\n* Cardiac conditions\n* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months\n* History irritable bowel syndrome, malabsorption or significant GI disease\n* History of kidney stones\n* Use of medications known to interact with vitamin C\n* Use of supplements containing vitamin C\n* Use of anticoagulants (warfarin), barbiturates, tetracycline antibiotics, beta-blockers, cyclosporine, prednisone, tricyclic antidepressants, diuretics and nitrate medications\n* History of or current diagnosis of cancer\n* Uncontrolled hypertension\n* History of diabetes, renal disease and/or liver disease\n* Unstable psychiatric disorder\n* History of or current immunocompromise\n* History of hemochromatosis or hemoglobinopathies\n* Participation in a clinical research trial \\<30 days\n* Use of acute medication w/in 72 hours of intervention\n* Unstable medications \\<90 days\n* Abnormal liver function\n* Serum creatinine \\> 1.5 x upper limit of normal (ULN)\n* Anemia of any etiology\n* Blood donation w/in the last 2 months\n* Allergy or sensitivity to test articles, foods or beverages provided during the study\n* Cognitive impairment and/or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01852903', 'briefTitle': 'Comparative Bioavailability of Two Forms of Vitamin C', 'organization': {'class': 'INDUSTRY', 'fullName': 'NBTY, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Placebo-controlled Crossover Study Comparing the Bioavailability of Two Forms of Vitamin C in Plasma and Leukocytes Over 24 Hours.', 'orgStudyIdInfo': {'id': '11CIHE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'calcium ascorbate', 'interventionNames': ['Dietary Supplement: calcium ascorbate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ascorbic acid', 'interventionNames': ['Dietary Supplement: ascorbic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'calcium ascorbate', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vitamin C'], 'armGroupLabels': ['calcium ascorbate']}, {'name': 'ascorbic acid', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['vitamin C'], 'armGroupLabels': ['ascorbic acid']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5R8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KGK Synergize Inc', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Dale R Wilson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KGK Science Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NBTY, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'KGK Science Inc.', 'class': 'INDUSTRY'}, {'name': 'Moyad, Mark MD MPH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}