To determine if the addition of weekly zinc and weekly zinc plus vitamin A to routine tuberculosis (TB) treatment improves the outcome of the treatment in Nigeria

ISRCTN	ISRCTN36636609
DOI	https://doi.org/10.1186/ISRCTN36636609
Secondary identifying numbers	N/A

Submission date: 24/06/2009
Registration date: 24/07/2009
Last edited: 23/10/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Lovett Lawson
Scientific

Zankli Medical Centre
1021, Shehu Yaradua Way
Abuja
P.O.Box 7745
Nigeria

Phone	+234 (0)803 701 2487
Email	lovettlawson@hotmail.com

Study information

Study design	Double-blinded block randomised placebo-controlled multicentre supplementation clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
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
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(s)	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)
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
Primary outcome measure	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 study start date	01/09/2003
Overall study end date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	350
Total final enrolment	350
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 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

Study participating centre

Zankli Medical Centre

Abuja
P.O.Box 7745
Nigeria

Sponsor information

Zankli Medical Centre (Nigeria)
Hospital/treatment centre

1021, Shehu Yaradua Way
Abuja
P.O.Box 7745
Nigeria

Phone	+234 (0)9 670 7273 4
Email	zankli@hotmail.com
Website	http://www.zankli.com
"ROR"	https://ror.org/02msz7b29

Funders

Funder type

Hospital/treatment centre

Zankli Medical Centre (Nigeria)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2010	23/10/2020	Yes	No

Editorial Notes

23/10/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.