NCT00419068

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2007

Typical duration for phase_3

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

September 30, 2009

Status Verified

September 1, 2009

Enrollment Period

2.7 years

First QC Date

January 5, 2007

Last Update Submit

September 29, 2009

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Time to sputum culture conversion

Secondary Outcomes (5)

  • Rate of bacillary kill

  • 2-month culture conversion rate

  • Time to sputum smear conversion

  • Weight change

  • Radiographic response

Interventions

CholecalciferolDRUG
Migliol Placebo OilDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Suspected smear positive pulmonary tuberculosis.
  • Age 18 years or older.
  • Written informed consent to participate.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Whipps Cross University Hospital NHS Trust

London, E11 1NR, United Kingdom

Location

Newham University Hospital NHS Trust

London, E13 8SL, United Kingdom

Location

London Chest Hospital

London, E2 9JX, United Kingdom

Location

Homerton University Hospital NHS Foundation Trust

London, E9 6SR, United Kingdom

Location

Related Publications (1)

  • Martineau AR, Timms PM, Bothamley GH, Hanifa Y, Islam K, Claxton AP, Packe GE, Moore-Gillon JC, Darmalingam M, Davidson RN, Milburn HJ, Baker LV, Barker RD, Woodward NJ, Venton TR, Barnes KE, Mullett CJ, Coussens AK, Rutterford CM, Mein CA, Davies GR, Wilkinson RJ, Nikolayevskyy V, Drobniewski FA, Eldridge SM, Griffiths CJ. High-dose vitamin D(3) during intensive-phase antimicrobial treatment of pulmonary tuberculosis: a double-blind randomised controlled trial. Lancet. 2011 Jan 15;377(9761):242-50. doi: 10.1016/S0140-6736(10)61889-2. Epub 2011 Jan 5.

    PMID: 21215445DERIVED

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Adrian R Martineau, MRCP

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

  • Christopher J Griffiths, FRCP FRCGP D Phil

    Queen Mary University of London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 8, 2007

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

September 30, 2009

Record last verified: 2009-09

Locations

GB(4)