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
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