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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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15 January 2018 |
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Main ID: |
ISRCTN08265004 |
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Date of registration:
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17/11/2011 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Studying the effect of vitamin D supplementation in human immunodeficiency virus (HIV) patients who have experienced loss of bone mineral density over time
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Scientific title:
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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 |
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Date of first enrolment:
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01/11/2011 |
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Target sample size:
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48 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN08265004 |
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Study type:
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Interventional |
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Study design:
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Phase IV open label study (Treatment)
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Phase:
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Phase IV
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Barry
Peters |
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Address:
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Harrison Wing
2nd Floor Lambeth Wing
St. Thomas' Hospital
Westminster Bridge Road
SE1 7EH
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Human immunodeficiency virus (HIV)
Infections and Infestations
HIV disease resulting in other specified conditions
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Intervention(s)
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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.
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Primary Outcome(s)
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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
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Secondary Outcome(s)
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No secondary outcome measures
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Source(s) of Monetary Support
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ViiV Pharmaceuticals (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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