Condition category
Infections and Infestations
Date applied
02/09/2011
Date assigned
17/11/2011
Last edited
24/08/2015
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 Barry Peters

ORCID ID

Contact details

Harrison Wing
2nd Floor Lambeth Wing
St. Thomas' Hospital
Westminster Bridge Road
London
SE1 7EH
United Kingdom

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 DekristolĀ®
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

http://www.kcl.ac.uk/nursing/partners/nhs/gstt.aspx

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

Publication citations

Additional files

Editorial Notes