Condition category
Infections and Infestations
Date applied
24/06/2009
Date assigned
24/07/2009
Last edited
24/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Lovett Lawson

ORCID ID

Contact details

Zankli Medical Centre
1021
Shehu Yaradua Way
Abuja
P.O.Box 7745
Nigeria
+234 (0)803 701 2487
lovettlawson@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Diagnosis of tuberculosis and the role of micronutrients in the treatment of pulmonary tuberculosis (PTB) in Nigeria: a double-blinded, placebo-controlled, multicentre, supplementation clinical trial

Acronym

Study hypothesis

To assess the efficacy of weekly zinc and weekly zinc plus vitamin A as an adjunct for the treatment of patients with tuberculosis (TB).

Ethics approval

1. Liverpool School of Tropical Medicine Research Ethics Committee approved on the 25th July 2003 (ref: 03.33)
2. Ministry of Federal Capital Territory, Health and Social Services Department, Nigeria approved on the 23rd June 2003 and 16th July 2003 (ref: MFCT/GEN/24/VOL1)

Study design

Double-blinded block randomised placebo-controlled multicentre supplementation clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Tuberculosis

Intervention

Patients were randomised in blocks to receive:
1. Anti-TB routine treatment plus 90 mg elementary zinc weekly (as zinc sulphate in a lactose matrix in form of a tablet) plus a placebo that looked identical to vitamin A
2. Anti-TB treatment plus 90 mg elementary zinc weekly plus 1500 retinol (equivalent to 5000 IU of vitamin A as retinyl acetate, in a capsular form)
3. Anti-TB treatment plus weekly placebos that were similar to zinc tablets and vitamin A capsules

All capsules and tablets were prepared and sent from the Liverpool School of Tropical Medicine. The tablets and the capsules were indistinguishable to both researchers and patients.

Total duration of treatment was 8 months and the total duration of the follow-up for all arms was 6 months.

Intervention type

Supplement

Phase

Not Specified

Drug names

Zinc, vitamin A supplementation

Primary outcome measures

1. To determine the time to sputum clearance of bacilli (proportion of TB bacilli cleared from sputum at enrolment, 2nd and 6th month, using smear microscopy in the three groups)
2. To determine the resolution of lesion areas in chest x-rays in the three groups at enrolment, 2nd and 6th month

Secondary outcome measures

To look at the clinical and laboratory differences between the three groups at enrolment, 2nd and 6th month.

Overall trial start date

01/09/2003

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Willingness to take part in the study
2. Newly diagnosed as having active PTB as per the World Health Organization (WHO) definition of smear positive TB
3. Aged 15 years and above, either sex
4. Should not have a history of anti-TB treatment

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

1. Moderate to severe surgery during the previous month
2. History of diabetes mellitus or severe cardiovascular, liver or renal diease
3. Previous treatment for TB
4. Taking corticosteroids, zinc or vitamin A supplementation during the previous month
5. Pregnant, lactating or taking oral contraceptives
6. Patient could not attend follow up visits regularly

Recruitment start date

01/09/2003

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Nigeria

Trial participating centre

Zankli Medical Centre
Abuja
P.O.Box 7745
Nigeria

Sponsor information

Organisation

Zankli Medical Centre (Nigeria)

Sponsor details

1021
Shehu Yaradua Way
Abuja
P.O.Box 7745
Nigeria
+234 (0)9 670 7273 4
zankli@hotmail.com

Sponsor type

Hospital/treatment centre

Website

http://www.zankli.com

Funders

Funder type

Hospital/treatment centre

Funder name

Zankli Medical Centre (Nigeria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes