Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT01873820
Status:
COMPLETED
Last Update Posted:
2013-06-10
First Post:
2013-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults
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': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'lastUpdateSubmitDate': '2013-06-06', 'studyFirstSubmitDate': '2013-05-14', 'studyFirstSubmitQcDate': '2013-06-06', 'lastUpdatePostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Gastrointestinal Symptom Rating Scale at 5 and 10 days', 'timeFrame': '0, 5 and 10 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitamin C', 'calcium ascorbate', 'ascorbic acid'], 'conditions': ['Tolerance']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the tolerance of two forms of vitamin C in adults with sensitivity to acidic foods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 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* Self-reported sensitivity to acidic foods\n* Agrees to consume a low vitamin C diet\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning to become pregnant during the trial\n* Use of medications known to interact with vitamin C or cause epigastric effects\n* Use of supplements containing containing vitamin C\n* Duodenal ulcer or gastric ulcer, gastritis, hiatus hernia, or gastroesophageal reflux disease (GERD) within past 3 months\n* Use of antacids and/or acid suppressors within 4 weeks of randomization\n* History of irritable bowel syndrome and related disorders\n* Alcohol use \\> 2 standard alcoholic drinks per day; alcohol or drug abuse within the past year\n* History of cardiac disease within the past 6 months\n* History of or current diagnosis of cancer\n* Uncontrolled hypertension\n* Unstable renal and/or liver disease\n* History of kidney stones\n* Unstable psychiatric disorder\n* History of or current immunocompromise\n* History of hemoglobinopathies\n* Participation in another clinical research trial \\<30 days\n* Abnormal liver function\n* Serum creatinine \\> 1.5 x upper limit of normal (ULN)\n* Anemia of any etiology\n* Uncontrolled and/or untreated thyroid disorder\n* BMI ≥ 35 kg/m2\n* Unstable medications \\<30 days\n* Allergy or sensitivity to test article ingredients\n* Cognitively impaired and/or unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT01873820', 'briefTitle': 'Tolerance of Two Forms of Vitamin C in Acid-sensitive Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'NBTY, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Crossover Study Comparing the Tolerance of Two Forms of Vitamin C in Acid Sensitive Adults', 'orgStudyIdInfo': {'id': '07EAHT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Calcium ascorbate -> ascorbic acid', 'interventionNames': ['Dietary Supplement: Calcium ascorbate', 'Dietary Supplement: Ascorbic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Ascorbic acid -> calcium ascorbate', 'interventionNames': ['Dietary Supplement: Calcium ascorbate', 'Dietary Supplement: Ascorbic acid']}], 'interventions': [{'name': 'Calcium ascorbate', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Ascorbic acid -> calcium ascorbate', 'Calcium ascorbate -> ascorbic acid']}, {'name': 'Ascorbic acid', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Ascorbic acid -> calcium ascorbate', 'Calcium ascorbate -> ascorbic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5R8', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'KGK Synergize, Inc', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'David Crowley, 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'}}}}