Studying the effect of vitamin D supplementation in human immunodeficiency virus (HIV) patients who have experienced loss of bone mineral density over time

ISRCTN	ISRCTN08265004
DOI	https://doi.org/10.1186/ISRCTN08265004
Secondary identifying numbers	PB002

Submission date: 02/09/2011
Registration date: 17/11/2011
Last edited: 21/12/2017

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 Barry Peters
Scientific

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

Study information

Study design	Phase IV open label study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please contact HW.Research@gstt.nhs.uk to request a patient information sheet
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
Study objectives	To explore the effects and potential benefits of high doses of vitamin D supplementation on various parameters of the immune system
Ethics approval(s)	NRES Committee London - Westminster, approval pending
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2011
Completion date	01/03/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	48
Key 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
Key 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
Date of first enrolment	01/11/2011
Date of final enrolment	01/03/2012

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St. Thomas' Hospital

London
SE1 7EH
United Kingdom

Sponsor information

King's College London - Guy's and St Thomas' NHS Foundation Trust (UK)
Hospital/treatment centre

Joint Clinical Trials Office
16th Floor Tower Wing
Guy's Hospital
Great Maze Pond
London
SE1 9RT
England
United Kingdom

Website	http://www.kcl.ac.uk/nursing/partners/nhs/gstt.aspx
"ROR"	https://ror.org/00j161312

Funders

Funder type

Industry

ViiV Pharmaceuticals (UK)

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

Editorial Notes

21/12/2017: No publications found, verifying study status with principal investigator.