Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
PB002
Study information
Scientific title
A prospective study of loss of bone mineral density in patients with HIV over time: implications for clinical practice and therapeutic options - Vitamin D sub study
Acronym
Study hypothesis
To explore the effects and potential benefits of high doses of vitamin D supplementation on various parameters of the immune system
Ethics approval
NRES Committee London - Westminster, approval pending
Study design
Phase IV open label study
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 contact HW.Research@gstt.nhs.uk to request a patient information sheet
Condition
Human immunodeficiency virus (HIV)
Intervention
There are no treatment arms, there are 3 cohorts: HIV positive (on treatment), HIV Positive (Naive), HIV Negative. All are given 200,000 units stat colecalciferol at baseline and followed up over a 12 week period by doing physical exam, blood samples and urine samples.
Intervention type
Supplement
Phase
Phase IV
Drug names
Colecalciferol (Vitamin D)
Primary outcome measures
1. Efficacy: level in serum vitamin D levels to be above those at baseline
2. Safety:
2.1. Routine: serum renal, liver, bone, glucose, Full Blood Count (FBC)
2.2. Vital signs including blood pressure (BP), pulse, temperature
2.3. Renal: urine dipstix (blood, protein, leukocytes, glucose), urine protein/creatinine (PCR)
2.4. Bone biochemisty to include: Vitamin D, parathyroid hormone, alkaline phosphatase (ALP)
Samples obtained at baseline, week 4 and week 12
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2011
Overall trial end date
01/03/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged between 18 years and 45 years , males and females
2. Documented Positive HIV-1 antibody test and either stable on highly active antiretroviral therapy (HAART) as defined by undetectable viral load and on the same regimen for more than 6 months or treatment naive (HIV+ cohort only) (n=32)
3. Presumed HIV negative C (HIV negative cohort only) (n=16)
4. Ability to give informed consent
5. Willing to use barrier method contraception (condoms) for the duration of the trial
6. Documented Vitamin D deficiency (less than 50 nmol/L within 6 months of screening)
7. Not currently taking Vitamin D supplements, or have taken any Vitamin D supplements within 4 weeks of screening
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
48
Participant exclusion criteria
1. Pregnancy or breast feeding
2. Patient unlikely to comply with protocol
3. Received vitamin D supplementation within the previous 4 weeks
4. Documented history of renal impairment
5. Any chronic inflammatory condition
6. Documented Hepatitis B or C
7. Documented soya or peanut allergy or hypersensitivity to any of the constituents of Dekristol®
8. Hypercalcaemia or hypercalciuria
9. Pseudohypoparathyroidism
Recruitment start date
01/11/2011
Recruitment end date
01/03/2012
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St. Thomas' Hospital
London
SE1 7EH
United Kingdom
Sponsor information
Organisation
King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)
Sponsor details
Joint Clinical Trials Office
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
ViiV Pharmaceuticals (UK)
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