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| Name | Class |
|---|---|
| The National HIV/AIDS Programme | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo Oil | Other | participants will receive placebo(olive oil) orally in all visits from visit 1 to visit 4 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Within 12 Weeks |
| To measure the effect of our intervention on PCR value copies/µL. |
| Measure | Description | Time Frame |
|---|---|---|
| To access the effect of the intervention on Lymphocytes | The units for Lymphocytes is in percentage % | within 12 weeks |
| To access the effect of intervention on Monocytes | The units for Monocytes is in percentage % |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Govt Said Mitha Teaching Hospital Lahore | Lahore | Punjab/ lahore/Pakistan | 5200 | Pakistan | ||
| Fatima Majeed |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 15, 2019 | Feb 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 15, 2019 | Feb 22, 2022 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 15, 2019 | Mar 14, 2022 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D014808 | Vitamin D Deficiency |
| ID | Term |
|---|---|
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
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| ID | Term |
|---|---|
| D000069463 | Olive Oil |
| C104450 | 25-hydroxyvitamin D |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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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.
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Its double blind trail so trail is blinded for Participants, Care Provider, Investigator and Outcome Assessor.
| 25-Hydroxyvitamin D | Drug | Participants will receive vitamin D (100000IU) orally during all visits i.e. from visit-1 to visit-4 |
|
|
PCR normal value is usually comes under detected and non-detected category and its unit is copies/µL
| 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. | within 12 weeks |
| To measure the effect of intervention on SGPT | The normal value of SGPT is measured in (µL) | Within 12 weeks |
| To measure the effect of intervention on SGOT | The normal value of SGOT is measured in (µL) | Within 12 weeks |
| To measure the effect of intervention on ALP | The normal value of ALP is measured in (µ/l) | Within 12 weeks |
| To measure the effect of intervention on Bilirubin | The normal value of Bilirubin measured in (mg/dl) | Within 12 weeks |
| within 12 weeks |
| To access the effect of intervention on Hemoglobin | The hemoglobin level is measured in g/dl | within 12 weeks |
| To access the effect of the intervention on Platelets count | The platelets count is normally measured in 1000/µL | Within 12 weeks. |
| To access the effect of the intervention on Eosionophil | The platelets count is normally measured in percentage % | Within 12 weeks |
| To access the effect of the intervention on Basophil | The Basophil count is normally measured in percentage % | Within 12 weeks |
| Lahore |
| Punjab/ lahore/Pakistan |
| LAHORE |
| Pakistan |
| D009750 |
| Nutritional and Metabolic Diseases |
| D005224 |
| Fats, Unsaturated |
| D010938 | Plant Oils |
| D009821 | Oils |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |