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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN08265004

Enrollment

Registered

2011-11-17

Start date

2011-11-01

Completion date

Unknown

Last updated

2018-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Human immunodeficiency virus (HIV) Infections and Infestations HIV disease resulting in other specified conditions

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
No secondary outcome measures	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026