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OpenTrials
Completed

NCT Number: NCT00419068

Trial of Adjunctive Vitamin D in Tuberculosis Treatment

The purpose of this study is to determine whether vitamin D enhances response to standard antibiotic treatment for pulmonary tuberculosis.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Homerton University Hospital NHS Foundation Trust, London, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

Migliol Placebo Oil

Drug

Primary outcomes

  1. Time to sputum culture conversion

Secondary outcomes

  1. Rate of bacillary kill

  2. 2-month culture conversion rate

  3. Time to sputum smear conversion

  4. Weight change

  5. Radiographic response

Sponsors and collaborators

Lead sponsor

Barts & The London NHS Trust

Other

Collaborators

  • British Lung Foundation

Registry information

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jan 8, 2007
Registry last updated
Sep 30, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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