- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00419068
Trial of Adjunctive Vitamin D in Tuberculosis Treatment
September 29, 2009 updated by: Barts & The London NHS Trust
The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
146
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
London, United Kingdom, E2 9JX
- London Chest Hospital
-
London, United Kingdom, E9 6SR
- Homerton University Hospital NHS Foundation Trust
-
London, United Kingdom, E11 1NR
- Whipps Cross University Hospital NHS Trust
-
London, United Kingdom, E13 8SL
- Newham University Hospital NHS Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Suspected smear positive pulmonary tuberculosis.
- Age 18 years or older.
- Written informed consent to participate.
Exclusion Criteria:
- Known intolerance of vitamin D or first-line anti-tuberculous therapy.
- Taking antituberculous therapy for more than six days in the six months preceding enrolment.
- Taking the following medication in the month preceding enrolment: oral corticosteroid therapy, immunosuppressant therapy or cytotoxic therapy.
- Taking the following medication at enrolment: benzothiadiazine derivatives, cardiac glycosides or antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol.
- Diagnosis of any of the following: sarcoidosis, hyperparathyroidism, nephrolithiasis, pulmonary silicosis, HIV infection, liver failure, renal failure or malignancy
- Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
- Biochemical disturbance at enrolment: serum corrected calcium >2.66 mmol/l, serum AST >120 IU/l, total serum bilirubin > 40 micromol/l or serum creatinine > 250 micromol/l
- Breastfeeding or pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Time to sputum culture conversion
|
Secondary Outcome Measures
Outcome Measure |
---|
Radiographic response
|
Weight change
|
Rate of bacillary kill
|
2-month culture conversion rate
|
Time to sputum smear conversion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Adrian R Martineau, MRCP, Queen Mary University of London
- Principal Investigator: Christopher J Griffiths, FRCP FRCGP D Phil, Queen Mary University of London
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2007
Primary Completion (Actual)
September 1, 2009
Study Completion (Actual)
September 1, 2009
Study Registration Dates
First Submitted
January 5, 2007
First Submitted That Met QC Criteria
January 5, 2007
First Posted (Estimate)
January 8, 2007
Study Record Updates
Last Update Posted (Estimate)
September 30, 2009
Last Update Submitted That Met QC Criteria
September 29, 2009
Last Verified
September 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Lung Diseases
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Mycobacterium Infections
- Tuberculosis
- Tuberculosis, Pulmonary
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- 2005-003562-42
- EudraCT no: 2005-003562-42
- REC ref: 06/Q0605/83
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Tuberculosis, Pulmonary
-
Foundation for Innovative New Diagnostics, SwitzerlandInstitute of Tropical Medicine, Belgium; Research Center Borstel; National Institute...CompletedMultidrug-Resistant Tuberculosis | Isoniazid Resistant Pulmonary Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses
-
Universiteit AntwerpenAurum Institute; University of Stellenbosch; University of the Free State; Free...RecruitingDrug-resistant Tuberculosis | Rifampicin Resistant Tuberculosis | Pulmonary Tuberculoses | Multidrug Resistant TuberculosisSouth Africa
-
Tjip van der WerfGadjah Mada University; The Enose Company, Zutphen the NetherlandsCompletedPulmonary Tuberculosis Suspected | Other Specified Chronic Obstructive Pulmonary Disease | Pulmonary Tuberculosis TB (+) Histology, (-) BacteriologyIndonesia
-
Research Institute of Epidemiology, Microbiology...Active, not recruitingAspergillosis | Pulmonary Tuberculoses | Old Tuberculosis | Active Tuberculosis | Chronic Pulmonary AspergillosisUzbekistan
-
Medecins Sans Frontieres, NetherlandsLondon School of Hygiene and Tropical Medicine; University of Liverpool; Ministry... and other collaboratorsCompletedMulti-drug Resistant Tuberculosis | Pulmonary Tuberculoses | Extensively Drug-Resistant TuberculosisBelarus, South Africa, Uzbekistan
-
Assistance Publique - Hôpitaux de ParisUnknownPulmonary Tuberculosis | Extra Pulmonary TuberculosisFrance
-
Hospital de Clinicas de Porto AlegreFederal University of Rio Grande do SulCompletedPulmonary Tuberculosis | Extra Pulmonary TuberculosisBrazil
-
Radboud University Medical CenterEuropean and Developing Countries Clinical Trials Partnership (EDCTP); Department... and other collaboratorsCompletedPulmonary Tuberculosis (TB)South Africa
-
National Institute of Allergy and Infectious Diseases...International Tuberculosis Research CenterWithdrawnRefractory Pulmonary TuberculosisKorea, Republic of
-
Assiut UniversityUnknownExtra Pulmonary Tuberculosis
Clinical Trials on Cholecalciferol
-
Medical University of South CarolinaTerminatedVitamin D Deficiency | Nutritional DeficiencyUnited States
-
Centre of Postgraduate Medical EducationUnknownInfant, Premature, DiseasesPoland
-
Johns Hopkins UniversityNational Institute on Aging (NIA)TerminatedVitamin D Deficiency | FallsUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic Fibrosis | Allergic Bronchopulmonary AspergillosisUnited States
-
Rashid Centre for Diabetes and ResearchCompletedObesity | Type 2 Diabetes Mellitus | Hypovitaminosis DUnited Arab Emirates
-
University Hospitals Cleveland Medical CenterUniversity of Colorado, DenverCompletedInflammationUnited States
-
University Hospital, AngersMylan LaboratoriesCompleted
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Assistance Publique - Hôpitaux de ParisLaboratoire CrinexCompletedRenal Transplant Candidate for Right KidneyFrance