Condition category
Infections and Infestations
Date applied
21/07/2005
Date assigned
23/08/2005
Last edited
14/09/2009
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 James Sparling

ORCID ID

Contact details

3400 Upper Terrace
Victoria,BC
V8R 6E6
Canada
+1 250 598 2829
sparling@horizon.bc.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

A nutritional supplement including selenium as L-selenomethione 600 mcg for the first month followed by 400 mcg for the duration of the study, the 3 amino acids (N-Acetylcysteine, L-glutamine, and Hydroxytryptophane), vitamins (A, B, C, E), and trace minerals will increase CD4 counts and improve quality of life over 48 weeks for HIV+ patients and thereby, delay the need for commencing antiretroviral virus (ARV) therapy

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

HIV antibody positive patients

Intervention

All patients attending the acquired immunodeficiency syndrome (AIDS) clinic at Mengo Hospital will be offered the opportunity to participate. After registration patients will be randomly assigned to 2 groups using a standard list of random numbers. The 'control' group will receive a standard mix of vitamins including A, B, C, E and minerals (excluding selenium). The 'treatment' group will receive the same vitamin mineral mixture plus L-selenomethionine 600 mcg for 4 weeks followed by 400 mcg for the duration and 3 essential amino acids N-Acetylcysteine 360 mg, L-Glutamine 360 mg and Hydroxytrptophane 360 mg. Cd4 counts and Glutathione Peroxidase levels will be measured initially and at weeks 24 and 48. Clinical parameters including symptoms, weight change, opportunistic infections, and quality of life questionnaire will be recorded every 6 weeks.

Intervention type

Supplement

Phase

Not Specified

Drug names

Selenium as L-selenomethione, the 3 amino acids (N-Acetylcysteine, L-glutamine, and Hydroxytryptophane), vitamins (A, B, C, E), and trace minerals

Primary outcome measures

1. Change in Cd4 counts and GPx
2. Improved quality of life

Secondary outcome measures

1. Delay progression of disease as measured by WHO staging and CD4 counts
2. Delay need to institute ARV therapy

Overall trial start date

01/05/2005

Overall trial end date

01/08/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Over 18 years
2. CD4 counts 200-500
3. Reside within 15 km of Mengo Hospital at a fixed address

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

350

Participant exclusion criteria

1. World Health Organisation (WHO) stage 4 disease
2. Pregnant and breast feeding women
3. Patients who have received selenium supplementation in the preceding 3 months
4. Patients currently receiving ARV therapy

Recruitment start date

01/05/2005

Recruitment end date

01/08/2006

Locations

Countries of recruitment

Uganda

Trial participating centre

3400 Upper Terrace
Victoria,BC
V8R 6E6
Canada

Sponsor information

Organisation

Friends of Mengo Hospital Canada (Canada)

Sponsor details

924 Richmond Avenue
Victoria
BC
V8S 3Z2
Canada
+1 250 595 5650
sparling@horizon.bc.ca

Sponsor type

Charity

Website

http://mengofriends.ca/

Funders

Funder type

Charity

Funder name

Private donations to Friends of Mengo Hospital Canada, a registered Canadian charity and NGO (Canada)

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