HIV-1-infectionPhase 3HDVDS-HIVTNCT05306704
High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients Trial
A Phase 3 study testing 25-Hydroxyvitamin D in people with HIV-1-infection and Hypovitaminosis D, run by University of the Punjab at 2 sites in Pakistan.
Trial summary
High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- HIV-1-infection, Hypovitaminosis D
- What is being tested?
- 25-Hydroxyvitamin D
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 2 sitesPakistan
- Study dates
- 15 Feb 2019to 31 Jan 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 19 years and above
- Vitamin-D levels less than 20ng/ml
- Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
- Written Informed Consent Form
- PCR Positive Patients
Who cannot join
- Pregnant and Lactating Women
- Ability to take Study Medication Orally
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Govt Said Mitha Teaching Hospital Lahore
Lahore, Punjab/ lahore/Pakistan, 5200
Fatima Majeed
Lahore, Punjab/ lahore/Pakistan, LAHORE
About this study
Official title: High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial
High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.
Read the detailed description
The study is designed to evaluate the effect of high dose Vitamin-D supplementation in the treatment of HIV patients with Antiretroviral therapy.
Furthermore, in secondary outcomes study will evaluate the effects of high dose vitamin-D supplementation by Pre \& Post assessments of CD4 count and PCR count.
Secondary outcomes also includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of SGPT, SGOT, ALP and Bilirubin.
Tertiary outcomes includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of Hb, Lymphocytes, Monocytes, Eosinophil, Platelet count and Basophil count.
A sample size of 95 patients were recruited in Said Mitha Teaching Hospital Lahore.
Study is planned in two groups including 1) ARV + Vitamin-D3 2) ARV + Placebo. Methods/design: A randomized placebo controlled double-blind clinical trial of patients with age 19-50 years.
The primary outcome will be assessed by analyzing the difference change in the Vitamin-D Levels from Day 1 to Week 12. Secondary outcomes including viral load count, CD4 count, elevated levels of LFTs, will also be assessed by analyzing the mean difference in their values on week 12 after the supplementation of high dose Vitamin-D. Tertiary outcomes (Hematology) including Hb, HCT, TLC, Eosinophil's count, Neutrophils count, Monocytes and Platelets Data will be collected on a predefined Performa. All information will be entered in SPSS for the analysis.
Discussion: High dose Vitamin D supplementation in HIV-infected patients has not been previously investigated in Pakistan and it is unknown whether increasing levels is associated with improved clinical outcome or not. Therefore, it is significant to conduct a study to know the effect of vitamin D in the treatment of HIV patients with antiretroviral therapy.
Keywords: AIDS, HIV, anti-retroviral therapy, high dose 25-hydroxy Vitamin-D level, CD4 count, viral load.
- Conditions
- HIV-1-infection, Hypovitaminosis D
- Being tested
- placebo Oil, 25-Hydroxyvitamin D
- Medical subject headings
- Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo OilOther
Also called Olive oil
participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4
25-Hydroxyvitamin DDrug
Also called viatamin-D
Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4
| Study group | Role | What they receive |
|---|---|---|
| Control Arm: Olive oil | Placebo comparator | In control arm participants will receive Placebo (Olive Oil) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list. Receives: Other: placebo Oil |
| Vitamin-D | Active comparator | In the Vitamin-D arm, participants will receive Vitamin-D (100000 IU) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list. Receives: Drug: 25-Hydroxyvitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients
Optimal level of Vitamin-D3 i.e >20ng/ml in HIV patients
Measured: Within 12 Weeks
Secondary outcomes (7)
The secondary outcome is to assess the mean differences in CD4 count
Optimal value of CD4 count is 500-1500 cells/mm3 the unit of CD4 count is cells/mm3
Measured: Within 12 Weeks
To measure the effect of our intervention on PCR value copies/µL.
PCR normal value is usually comes under detected and non-detected category and its unit is copies/µL
Measured: within 12 weeks
To measure the effect of intervention on the viral load value
The normal value of viral load must be zero and measures in copies/µL of the blood.
Measured: within 12 weeks
To measure the effect of intervention on SGPT
The normal value of SGPT is measured in (µL)
Measured: Within 12 weeks
To measure the effect of intervention on SGOT
The normal value of SGOT is measured in (µL)
Measured: Within 12 weeks
To measure the effect of intervention on ALP
The normal value of ALP is measured in (µ/l)
Measured: Within 12 weeks
To measure the effect of intervention on Bilirubin
The normal value of Bilirubin measured in (mg/dl)
Measured: Within 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start15 Feb 2019
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group trial design. Parallel arm design is the most commonly used study design. In this design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Collaborators
- The National HIV/AIDS Programme
- Responsible party
- Principal investigator, Fatima Majeed, Services Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306704
- Sponsor's protocol ID
- 12121218
- Acronym
- HDVDS-HIVT
- Status last verified
- Apr 2022
- First submitted
- 21 Apr 2021
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-Dose Vitamin D3 Supplementation in the Treatment of Human Immune Deficiency Virus Patients: A Double-Blind Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05306704
- Acronym / sponsor ID
- HDVDS-HIVT / 12121218
- Conditions
- HIV-1-infection, Hypovitaminosis D
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Collaborators
- The National HIV/AIDS Programme
- Study start
- 15 Feb 2019 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
High-Dose Vitamin D3 in the Treatment of Human Immune Deficiency Virus Patients, A Double-Blind Randomized Control Trial Human immunodeficiency virus is a key challenge for global health. Vitamin D deficiency is common in people living with HIV infection. Antiretroviral therapy may create unique risk factors for vitamin D insufficiency, including alterations of vitamin D metabolism by ART.
Detailed description
The study is designed to evaluate the effect of high dose Vitamin-D supplementation in the treatment of HIV patients with Antiretroviral therapy.
Furthermore, in secondary outcomes study will evaluate the effects of high dose vitamin-D supplementation by Pre \& Post assessments of CD4 count and PCR count.
Secondary outcomes also includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of SGPT, SGOT, ALP and Bilirubin.
Tertiary outcomes includes the effects of high dose vitamin-D supplementation by Pre \& Post assessments of Hb, Lymphocytes, Monocytes, Eosinophil, Platelet count and Basophil count.
A sample size of 95 patients were recruited in Said Mitha Teaching Hospital Lahore.
Study is planned in two groups including 1) ARV + Vitamin-D3 2) ARV + Placebo. Methods/design: A randomized placebo controlled double-blind clinical trial of patients with age 19-50 years.
The primary outcome will be assessed by analyzing the difference change in the Vitamin-D Levels from Day 1 to Week 12. Secondary outcomes including viral load count, CD4 count, elevated levels of LFTs, will also be assessed by analyzing the mean difference in their values on week 12 after the supplementation of high dose Vitamin-D. Tertiary outcomes (Hematology) including Hb, HCT, TLC, Eosinophil's count, Neutrophils count, Monocytes and Platelets Data will be collected on a predefined Performa. All information will be entered in SPSS for the analysis.
Discussion: High dose Vitamin D supplementation in HIV-infected patients has not been previously investigated in Pakistan and it is unknown whether increasing levels is associated with improved clinical outcome or not. Therefore, it is significant to conduct a study to know the effect of vitamin D in the treatment of HIV patients with antiretroviral therapy.
Keywords: AIDS, HIV, anti-retroviral therapy, high dose 25-hydroxy Vitamin-D level, CD4 count, viral load.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel group trial design. Parallel arm design is the most commonly used study design. In this design, subjects are randomized to one or more study arms and each study arm will be allocated a different intervention.
| Arm | Type | Receives |
|---|---|---|
| Control Arm: Olive oil | Placebo comparator | Other: placebo OilIn control arm participants will receive Placebo (Olive Oil) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list. |
| Vitamin-D | Active comparator | Drug: 25-Hydroxyvitamin DIn the Vitamin-D arm, participants will receive Vitamin-D (100000 IU) orally in all visits i.e from visit 1 to visit 4. Allocation of arms will be as per the pre-created random list. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age from 19 years and above
- Vitamin-D levels less than 20ng/ml
- Not taking any kind of Vitamin-D supplementation or Mega Doses for last six months
- Written Informed Consent Form
- PCR Positive Patients
Key exclusion criteria (2 listed)
- Pregnant and Lactating Women
- Ability to take Study Medication Orally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| placebo OilAlso: Olive oilparticipants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4 | Other | Control Arm: Olive oil |
| 25-Hydroxyvitamin DAlso: viatamin-DParticipants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4 | Drug | Vitamin-D |
Primary outcome
Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients
Time frame: Within 12 Weeks
Optimal level of Vitamin-D3 i.e >20ng/ml in HIV patients
7 secondary outcomes
The secondary outcome is to assess the mean differences in CD4 count
Time frame: Within 12 Weeks
To measure the effect of our intervention on PCR value copies/µL.
Time frame: within 12 weeks
To measure the effect of intervention on the viral load value
Time frame: within 12 weeks
To measure the effect of intervention on SGPT
Time frame: Within 12 weeks
To measure the effect of intervention on SGOT
Time frame: Within 12 weeks
To measure the effect of intervention on ALP
Time frame: Within 12 weeks
To measure the effect of intervention on Bilirubin
Time frame: Within 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 25-Hydroxyvitamin D in people with HIV-1-infection and Hypovitaminosis D, run by University of the Punjab at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome is to achieve normal physiological level by Vitaman-D3 supplementation in HIV positive patients (time frame: Within 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2022.