Dietary Supplements to Reduce Symptom Severity and Duration in People With SARS-CoV-2: A Randomized, Double Blind, Placebo Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Participant-reported Overall Health
研究概览
简要总结
This is a double blind, placebo controlled, phase III randomized controlled trial evaluating the effects of the dietary supplements vitamin C, vitamin D, vitamin K, and zinc versus placebo on the overall health, symptom severity, and symptom duration of outpatients diagnosed with SARS-CoV-2.
详细描述
This study proposed is a double-blind, placebo-controlled, phase III randomized controlled trial powered to detect meaningful differences in the overall health and symptom severity of people with COVID-19 between the treatment and control arms. Eligible participants will be randomly assigned, using a web randomization system, in a ratio of 1:1 to one of the following groups: (1) nutrient therapy with vitamin D, vitamin C, vitamin K2, and zinc or (2) placebo. Total trial duration will be 12 weeks. Nutrients or placebo will be given for a period of 21 days following enrolment and randomization. Total trial duration will be 12 weeks. Adverse events will be collected during the treatment phase plus one additional week (maximum 4 weeks).
With respect to the primary outcome of participant-reported overall health, power calculations were conducted based on between-group differences at a single time point (21 days) and Cohen's guideline for a small effect size of 0.3. A sample size of 176 (88 per arm) provides 80% power to detect a difference at an α of 0.05. To account for an approximate 10-15% lost to follow-up we will enrol 200 participants (100 per arm).
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (≥18) who test positive for SARS-CoV-2 in an outpatient setting
- •Access to internet
排除标准
- •Symptom onset greater than 4 days prior to enrolment
- •Supplementing regularly with >500 mg vitamin C, >1000 units vitamin D, >120 mcg vitamin K (any form), or >15 mg zinc taken daily within the past month
- •Currently taking warfarin or an equivalent vitamin K antagonist anticoagulant
- •End stage chronic kidney disease
- •History of calcium oxalate kidney stones
- •Active granulomatosis (sarcoidosis, tuberculosis, lymphoma)
- •Known hypercalcemia or hypervitaminosis D
- •Currently taking either of the following antibiotics: cephalexin, tetracyclines
- •Participating in an investigational study or participation in an investigational study within the past 30 days
- •Any reason which, under the discretion of the qualified investigator or delegate, would preclude the patient from participating.
研究组 & 干预措施
Treatment
Specific Product: Vitamin D3 50,000 IU
Formulation: Capsule. Each capsule will contain 500 mg (50,000 units) cholecalciferol (vitamin D3) Dose: One capsule on day 1 of the intervention period
Specific Product: Vitamin K2/D
Formulation: Liquid. Each 0.0285 mL drop contains 30 mcg menaquinone-7 (MK-7, vitamin K2) and 3.125 mcg (125 units) cholecalciferol (vitamin D3).
Dose: 0.114 mL (four drops) twice daily for 21 days totalling 240mcg MK-7 and 1,000 units cholecalciferol per day.
Specific Product: Vitamin C/Zinc
Formulation: Capsule. Each capsule will contain 666 mg ascorbic acid (vitamin C) and 8.3 mg of zinc acetate Dose: Three capsules three times daily for 21 days totalling 6 g ascorbic acid and 75 mg zinc acetate per day.
干预措施: Vitamin D3 50,000 IU (Drug)
Treatment
Specific Product: Vitamin D3 50,000 IU
Formulation: Capsule. Each capsule will contain 500 mg (50,000 units) cholecalciferol (vitamin D3) Dose: One capsule on day 1 of the intervention period
Specific Product: Vitamin K2/D
Formulation: Liquid. Each 0.0285 mL drop contains 30 mcg menaquinone-7 (MK-7, vitamin K2) and 3.125 mcg (125 units) cholecalciferol (vitamin D3).
Dose: 0.114 mL (four drops) twice daily for 21 days totalling 240mcg MK-7 and 1,000 units cholecalciferol per day.
Specific Product: Vitamin C/Zinc
Formulation: Capsule. Each capsule will contain 666 mg ascorbic acid (vitamin C) and 8.3 mg of zinc acetate Dose: Three capsules three times daily for 21 days totalling 6 g ascorbic acid and 75 mg zinc acetate per day.
干预措施: Vitamin C/Zinc (Dietary Supplement)
Treatment
Specific Product: Vitamin D3 50,000 IU
Formulation: Capsule. Each capsule will contain 500 mg (50,000 units) cholecalciferol (vitamin D3) Dose: One capsule on day 1 of the intervention period
Specific Product: Vitamin K2/D
Formulation: Liquid. Each 0.0285 mL drop contains 30 mcg menaquinone-7 (MK-7, vitamin K2) and 3.125 mcg (125 units) cholecalciferol (vitamin D3).
Dose: 0.114 mL (four drops) twice daily for 21 days totalling 240mcg MK-7 and 1,000 units cholecalciferol per day.
Specific Product: Vitamin C/Zinc
Formulation: Capsule. Each capsule will contain 666 mg ascorbic acid (vitamin C) and 8.3 mg of zinc acetate Dose: Three capsules three times daily for 21 days totalling 6 g ascorbic acid and 75 mg zinc acetate per day.
干预措施: Vitamin K2/D (Dietary Supplement)
Control
Specific Product: Vitamin D3 50,000 IU
Placebo Equivalent: microcrystalline cellulose capsule, 350 mg
Specific Product: Vitamin K2/D
Placebo Equivalent: Medium chain triglyceride oil
Specific Product: Vitamin C/Zinc
Placebo Equivalent: microcrystalline cellulose capsule, 350 mg
干预措施: Microcrystalline Cellulose Capsule (Other)
Control
Specific Product: Vitamin D3 50,000 IU
Placebo Equivalent: microcrystalline cellulose capsule, 350 mg
Specific Product: Vitamin K2/D
Placebo Equivalent: Medium chain triglyceride oil
Specific Product: Vitamin C/Zinc
Placebo Equivalent: microcrystalline cellulose capsule, 350 mg
干预措施: Medium Chain Triglyceride Oil (Other)
结局指标
主要结局
Participant-reported Overall Health
时间窗: During the intervention period (Daily for 21 days)
Measured using the EuroQol Visual Assessment Scale (EQ-VAS). Scores each day range from 0 (worst health imaginable) and 100 (best health imaginable). Scores summed over a 21-day period for a total range of 0-2100.
次要结局
- Effect of COVID-19 on the Health Status of Participants(Baseline plus weeks 1, 2, 3, 4, 8, and 12)
- Symptom Severity of Common COVID-19 Symptoms(During the intervention period (Daily for 21 days))
- Total Symptom Duration(During the intervention period (21 days))
- Incidence of Delayed Return to Usual Health(12 weeks)
- Number of Participants With a Hospital Visit or Admission(12 weeks)