Efficacy of Treatment With Vitamin D in Patients Diagnosed With COVID-19 Who Presenting Vitamin D Deficiency and Pneumonia.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- MORTALITY
研究概览
简要总结
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
详细描述
HYPOTHESIS: The administration of vitamin D supplements to patients who have a positive diagnosis for SARS-Cov-2, acute pneumonia requiring hospital admission and vitamin D deficiency have a more favourable evolution than subjects not treated with vitamin D (placebo). This favourable evolution will translate into a reduction in mortality, fewer ICU admissions and fewer days of stay in hospital.
OBJECTIVES:
PRINCIPAL: To assess whether the group of patients receiving vitamin D supplements have a less severe evolution of their acute pneumonia, translated into lower mortality, than patients who do not receive that supplement.
SECONDARY: 1) To determine the number of intensive care admissions and the number of days of admission in both groups (control group and intervention group). 2) To estimate the prevalence of Vitamin D deficiency in the patients studied and the effectiveness of its supplementation. 3) To establish the degree of complexity of each study group and carry out a cost-effectiveness study.
METHODOLOGY: DESIGN: Clinical trial, randomized, placebo-controlled and double-blind, with two parallel groups The active treatment will be vitamin D (Hydroferol soft capsules of 0.266 mg). The placebo will consist of a tablet with the same external characteristics and with the same treatment scheme but which will not contain any vitamin D active ingredients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Triple-blind study, neither the patients, nor the researchers, nor those responsible for the statistical analysis will know the treatment that the patient is undergoing.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted to the Respiratory or Internal medicine Units of Santiago hospital (HUA) due to pneumonia.
- •Vitamin D deficiency (25(OH) defined by blood levels below 30 mg/ml.
- •Possibility for observation during the treatment period.
- •Signing of written consent (oral informed consent exceptionally).
- •Positive PCR for diagnosis of sars-cov2 infection
排除标准
- •Patients taking any type of vitamin D supplement.
- •Patients with hypoparathyroidism.
- •Pregnant or lactating women.
- •Patients in whom the administration of vitamin D is formally contraindicated (see annex VI).
- •Patients who at time of inclusion, cannot take vitamin D orally.
研究组 & 干预措施
D VITAMIN GROUP
The administration of vitamin D will be carried out using the following treatment scheme:
If vitamin D deficiency (< 30 ng/ml) treatment with 2 capsules of 0.266 mg If vitamin D deficiency (< 40 ng/ml): treatment with 1 capsule of 0.266 mg
Blood levels of vitamin D will be determined on day 1, 4, 7 and 14. Based on the results from day 14, a new determination is recommended 4 weeks after starting treatment with the primary care physician who will decide whether to continue or interrupt the treatment. This phase will be carried out outside of the study.
In addition, the product should only be administered, if blood calcium and phosphorus levels are within normal limits, as well as if the creatinuria/calciuria ratio is within normal ranges.
干预措施: Vitamin D (Drug)
PLACEBO GROUP
The procedure will be the same as in the experimental group but instead of the active component, patients will take placebo capsules exactly the same as above but without the active component.
干预措施: PLACEBO (Drug)
结局指标
主要结局
MORTALITY
时间窗: At 21 days.
Mortality reduction
次要结局
- Incremental cost effectiveness ratio (ICER)(At 21 days)
- Intensive care admissions(At 21 days)
- Prevalence of vitamin D deficiency(At baseline)
- Length of hospital stay(AT 21 DAYS)