Trial of Adjunctive Vitamin D in Tuberculosis Treatment (AdjuVIT) - Trial of Adjunctive Vitamin D in Tuberculosis Treatment (AdjuVIT)

Phase 1

• Conditions: Pulmonary tuberculosis; MedDRA version: 8.1Level: LLTClassification code 10037440Term: Pulmonary tuberculosis

• Registration Number: EUCTR2005-003562-42-GB
• Lead Sponsor: Queen Mary, University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2008-01-11
• Study Completion: 2009-08-25
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

Age 18 years or older
Suspected pulmonary tuberculosis (with or without extrapulmonary tuberculosis) with acid-fast bacilli in a stained sputum smear
If a woman of child-bearing potential, has negative pregnancy test and agrees to use reliable form of contraception for at least 8 months
Willing and able to travel to Homerton Hospital TB Clinic for sputum induction if necessary, and contactable by telephone
Gives written informed consent to participate

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Known intolerance of vitamin D or first-line anti-tuberculous therapy
Known sarcoidosis, hyperparathyroidism or nephrolithiasis
Taking benzothiadiazine derivatives or cardiac glycosides
Specific comorbidity (known malignancy, known liver failure, known renal failure, known pulmonary silicosis, known HIV infection)
Taking oral corticosteroid therapy, immuno-suppressant therapy or cytotoxic drug in the month preceding enrollment
Taking antituberculous therapy for more than 7 days in the 6 months preceding enrolment
Taking antituberculous therapy other than rifampicin, isoniazid, pyrazinamide and ethambutol at time of enrollment
Infection with rifampicin-resistant organism (as demonstrated by rapid molecular testing)
Serum corrected calcium >2.66 mmol/l
Serum AST >3 x ULN
Total serum bilirubin > 2.5 x ULN
Serum creatinine > 2 x ULN
Breastfeeding
Planned travel out of London area within 8 weeks of enrollment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified