Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-28 @ 6:13 PM
Study NCT ID:
NCT04641195
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2020-11-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'C030691', 'term': 'gluconic acid'}, {'id': 'D015032', 'term': 'Zinc'}, {'id': 'D014807', 'term': 'Vitamin D'}], 'ancestors': [{'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D019216', 'term': 'Metals, Heavy'}, {'id': 'D004602', 'term': 'Elements'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D028561', 'term': 'Transition Elements'}, {'id': 'D008670', 'term': 'Metals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL', 'interventionModelDescription': 'The effect of both interventions (vitamin D or zinc) will be investigated simultaneously using a factorial design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 181}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-15', 'studyFirstSubmitDate': '2020-11-19', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to recovery', 'timeFrame': 'Up to 8 weeks', 'description': 'Defined as resolution of fever, cough and shortness of breath relative to baseline'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Necessity for assisted ventilation', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Individual symptoms duration', 'timeFrame': 'Up to 8 weeks'}, {'measure': 'Vitamin D', 'timeFrame': 'At 8 weeks'}, {'measure': 'Zinc', 'timeFrame': 'At 8 weeks'}, {'measure': 'Interleukin 6 (IL-6)', 'timeFrame': 'At 8 weeks'}, {'measure': 'Angiopoietin-2', 'timeFrame': 'At 8 weeks'}, {'measure': 'sTREM-1', 'timeFrame': 'At 8 weeks'}, {'measure': 'Immunoglobulin M (IgM)', 'timeFrame': 'At 8 weeks'}, {'measure': 'Immunoglobulin (IgG)', 'timeFrame': 'At 8 weeks'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'Up to 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'Vitamin-D3', 'Zinc', 'Nutrition support', 'Host-directed therapy', 'Clinical management', 'India'], 'conditions': ['COVID-19']}, 'referencesModule': {'references': [{'pmid': '37560461', 'type': 'DERIVED', 'citation': "Partap U, Sharma KK, Marathe Y, Wang M, Shaikh S, D'Costa P, Gupta G, Bromage S, Hemler EC, Mistry N, Kain KC, Dholakia Y, Fawzi WW. Vitamin D and Zinc Supplementation to Improve Treatment Outcomes among COVID-19 Patients in India: Results from a Double-Blind Randomized Placebo-Controlled Trial. Curr Dev Nutr. 2023 Jul 11;7(8):101971. doi: 10.1016/j.cdnut.2023.101971. eCollection 2023 Aug."}, {'pmid': '36366796', 'type': 'DERIVED', 'citation': 'Martineau AR. Vitamin D in the prevention or treatment of COVID-19. Proc Nutr Soc. 2023 May;82(2):200-207. doi: 10.1017/S0029665122002798. Epub 2022 Nov 11.'}, {'pmid': '36038172', 'type': 'DERIVED', 'citation': "Sharma KK, Partap U, Mistry N, Marathe Y, Wang M, Shaikh S, D'Costa P, Gupta G, Bromage S, Hemler EC, Kain KC, Dholakia Y, Fawzi WW. Randomised trial to determine the effect of vitamin D and zinc supplementation for improving treatment outcomes among patients with COVID-19 in India: trial protocol. BMJ Open. 2022 Aug 29;12(8):e061301. doi: 10.1136/bmjopen-2022-061301."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of vitamin D and/or zinc supplementation on improving COVID-19 treatment outcomes. The effects of vitamin D, zinc, and both vitamin D and zinc together will be investigated among COVID-19 patients in India.', 'detailedDescription': 'This study is a 2x2 factorial randomized double-blind, placebo-controlled trial to examine the effectiveness of vitamin D and zinc supplements as immune-based therapy among COVID-19 patients in India. The study is also examining the immunological response to COVID-19 and the effect of the intervention on specific biomarkers of immune and endothelial activation that are independent and quantitative predictors of severity and mortality in other severe infections. The primary aims are to determine the effect of vitamin D supplementation versus placebo on time to recovery among patients hospitalized with COVID-19; and to determine the effect of zinc supplementation versus placebo on time to recovery among patients hospitalized with COVID-19. As secondary aims, this study is also investigating the effect of vitamin D or zinc supplementation on all-cause mortality. necessity for assisted ventilation, individual symptoms duration, duration of hospital stay and biomarkers including vitamin D, Zinc, Interleukin 6 (IL-6), Angiopoietin-2, sTREM-1, immunoglobulin G (IgG) and immunoglobulin M (IgM).\n\nEligible individuals are randomly assigned to one of four groups: (1) Vitamin D (180,000 IU bolus at enrollment, followed by 2000 IU daily); (2) Zinc (placebo at enrollment followed by one daily dose of 40 mg); (3) Vitamin D and Zinc; or (4) Placebo. Daily supplements start at the hospital and continue after discharge for a total of 8 weeks. Active data collection occurs daily while patients are hospitalized and at least twice per week via telephone after discharge. A clinical exam occurs at 8 weeks and longer-term symptoms are assessed at 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged \\>=18 years old\n* Polymerase chain reaction (PCR) or Rapid Antigen Test (RAT)-confirmed infection with SARS-COV2\n* Provide informed consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Enrollment in other clinical trials'}, 'identificationModule': {'nctId': 'NCT04641195', 'briefTitle': 'Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India', 'organization': {'class': 'OTHER', 'fullName': 'Harvard School of Public Health (HSPH)'}, 'officialTitle': 'A Randomized Trial to Determine the Effect of Vitamin D and Zinc Supplementation for Improving Treatment Outcomes Among COVID-19 Patients in India', 'orgStudyIdInfo': {'id': 'VR3- 172649'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo- Placebo', 'description': 'Participants in the PLACEBO-PLACEBO group will receive a placebo vitamin D bolus at the hospital followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D- Placebo', 'description': 'Participants in the VITAMIN D-PLACEBO group will receive an actual vitamin D bolus at the hospital followed by actual daily vitamin D maintenance doses and daily placebo zinc supplements.', 'interventionNames': ['Dietary Supplement: Vitamin D3 (cholecalciferol)']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo-Zinc', 'description': 'Participants in the PLACEBO-ZINC group will receive a placebo vitamin D bolus at the hospital followed by placebo daily vitamin D maintenance doses and actual daily zinc supplements.', 'interventionNames': ['Dietary Supplement: Zinc (zinc gluconate)']}, {'type': 'EXPERIMENTAL', 'label': 'Vitamin D- Zinc', 'description': 'Participants in the VITAMIN D-ZINC group will receive an actual vitamin D bolus at the hospital followed by actual daily vitamin D maintenance doses and actual daily zinc supplements.', 'interventionNames': ['Dietary Supplement: Zinc (zinc gluconate) & Vitamin D (cholecalciferol)']}], 'interventions': [{'name': 'Vitamin D3 (cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'description': '180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks', 'armGroupLabels': ['Vitamin D- Placebo']}, {'name': 'Zinc (zinc gluconate)', 'type': 'DIETARY_SUPPLEMENT', 'description': '40mg of zinc gluconate taken once per day from enrollment to 8 weeks', 'armGroupLabels': ['Placebo-Zinc']}, {'name': 'Zinc (zinc gluconate) & Vitamin D (cholecalciferol)', 'type': 'DIETARY_SUPPLEMENT', 'description': '180,000 IU of vitamin D3 at enrollment, followed by 2000 IU of vitamin D3 and 40mg of zinc gluconate once per day from enrollment to 8 weeks', 'armGroupLabels': ['Vitamin D- Zinc']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.', 'armGroupLabels': ['Placebo- Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mumbai', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Saifee Hospital', 'geoPoint': {'lat': 19.07283, 'lon': 72.88261}}, {'city': 'Pune', 'state': 'Maharashtra', 'country': 'India', 'facility': 'King Edward Memorial (KEM) Hospital', 'geoPoint': {'lat': 18.51957, 'lon': 73.85535}}], 'overallOfficials': [{'name': 'Wafaie W Wafaie, MBBS, MPH, MS, DrPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Harvard School of Public Health (HSPH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Harvard School of Public Health (HSPH)', 'class': 'OTHER'}, 'collaborators': [{'name': 'Foundation for Medical Research', 'class': 'OTHER'}, {'name': 'University Health Network, Toronto', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nutrition, Epidemiology, and Global Health', 'investigatorFullName': 'Wafaie Fawzi', 'investigatorAffiliation': 'Harvard School of Public Health (HSPH)'}}}}