A nutritional supplement for human immunodeficiency virus (HIV) antibody positive patients at Mengo Hospital, Kampala, Uganda

ISRCTN	ISRCTN42274642
DOI	https://doi.org/10.1186/ISRCTN42274642
Secondary identifying numbers	N/A

Submission date: 21/07/2005
Registration date: 23/08/2005
Last edited: 14/09/2009

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr James Sparling
Scientific

3400 Upper Terrace
Victoria,BC
V8R 6E6
Canada

Phone	+1 250 598 2829
Email	sparling@horizon.bc.ca

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2005
Completion date	01/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	350
Key inclusion criteria	1. Over 18 years 2. CD4 counts 200-500 3. Reside within 15 km of Mengo Hospital at a fixed address
Key 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
Date of first enrolment	01/05/2005
Date of final enrolment	01/08/2006

Locations

Countries of recruitment

Canada
Uganda

Study participating centre

3400 Upper Terrace

Victoria,BC
V8R 6E6
Canada

Sponsor information

Friends of Mengo Hospital Canada (Canada)
Charity

924 Richmond Avenue
Victoria, BC
V8S 3Z2
Canada

Phone	+1 250 595 5650
Email	sparling@horizon.bc.ca
Website	http://mengofriends.ca/

Funders

Funder type

Charity

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

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