This is a pilot study to see how giving HIV infected patients, who have Vitamin D deficiency (and are already taking standard therapy) a high dose of vitamin D will affect the levels of vitamin D in their bodies and if this will help them have a better immune response to their infection.

Effects of Vitamin D supplementation on Vitamin D levels and immune activation in HIV infected individuals on antiretroviral therapy-A pilot study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-022775-57-GB

Enrollment

Registered

2011-05-13

Start date

2011-06-09

Completion date

Unknown

Last updated

2018-11-26

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

Conditions

HIV infected patients with vitamin D defficiency MedDRA version: 14.1 Level: LLT Classification code 10020189 Term: HIV test positve System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10020180 Term: HIV positive System Organ Class: 10022891 - Investigations MedDRA version: 14.1 Level: LLT Classification code 10020160 Term: HIV disease System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1 Level: LLT Classification code 1

Interventions

Trade Name: Adcal-D3 Lemon Chewable Tablets Pharmaceutical Form: Chewable tablet CAS Number: 471-34-1 Other descriptive name: CALCIUM CARBONATE Concentration unit: mg milligram(s) Concentration type:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Male and female -HIV infected patients on antiretroviral therapy - Between 18-65 years of age -Vitamin D deficiency [25(OH) vit D =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: -HIV infected individuals not receiving antiretroviral therapy. -Patients with normal Vitamin D levels (> 40 mmol/L) -Patients taking Vitamin D supplements -Documented soya or peanut allergy -Patients unable to provide written consent or comply with protocol -Pregnancy or trying to become pregnant -Documented osteoporosis requiring treatment -Participation on any other interventional study.

Design outcomes

Primary

Measure	Time frame
Main Objective: Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.;Secondary Objective: To investigate the effect of vitamin D on: 1. Immune activation (CD8 CD38) 2. Surrogate markers of clinical outcome (CD4 and HIV RNA) 3. active Vitamin D (1,25OH) 4. Markers of coagulation and inflammation [D-dimer, CRP] 5. Parathyroid hormone levels ;Primary end point(s): 25(OH) Vitamin D level at week 48;Timepoint(s) of evaluation of this end point: 48 weeks	—

Measure

Time frame

Main Objective: Investigate the role vitamin D supplementation on restoring vitamin D levels in HIV infected individuals on antiretroviral therapy.;Secondary Objective: To investigate the effect of vitamin D on: 1. Immune activation (CD8 CD38) 2. Surrogate markers of clinical outcome (CD4 and HIV RNA) 3. active Vitamin D (1,25OH) 4. Markers of coagulation and inflammation [D-dimer, CRP] 5. Parathyroid hormone levels ;Primary end point(s): 25(OH) Vitamin D level at week 48;Timepoint(s) of evaluation of this end point: 48 weeks

—

Secondary

Measure	Time frame
Secondary end point(s): 1. Immune activation (CD8 CD38) 2. Surrogate markers of clinical outcome (CD4 and HIV RNA) 3. active Vit D (1,25OH) 4. Markers of coagulation and inflammation [D-dimer, CRP] 5. Parathyroid hormone levels 6. Changes in bone density from DXA scan ;Timepoint(s) of evaluation of this end point: 48 weeks	—

Countries

United Kingdom

Contacts

Public ContactDr Julie Fox

Guy's and St Thomas' NHS Foundation Trust

julie.fox@kcl.ac.uk00440207188 7188

Outcome results

None listed

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