Vitamin Therapy in JGH Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- mood
研究概览
简要总结
There is a high prevalence of hypovitaminosis C and D in our hospital and other acute-care hospitals. Since the correction of these presumed deficiency states is simple, safe and inexpensive, their documented or suspected presence would normally be considered sufficient indication to correct them. However, the common practice is to ignore them. Identification of specific measurable medical consequences of hypovitaminosis C or D would provide a stronger case to treat or prevent in-hospital vitamin deficiency states.
Biochemical deficiencies of vitamin C and D have both been linked to mood disturbance, and hypovitaminosis C reportedly increases blood histamine concentrations.
We recently found that the provision of vitamin C (500 mg twice daily) but not vitamin D (1000 IU twice daily) promptly improved the average mood score of acutely hospitalized patients. We will now conduct a closely similar randomized clinical trial using a more adequate dose of vitamin D, namely 5000 IU/day for up to 10 days.
详细描述
HYPOTHESIS:
Adequate vitamin C or vitamin D provision to mentally competent acutely hospitalized patients for 7 to 10 days will correct their biochemical deficiency, improve their mood, and (in the vitamin C-treated patients) reduce blood histamine concentrations.
PROTOCOL:
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Mentally competent patients fluent in English or French admitted to the surgical or medical units of the hospital will be offered participation.
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Plasma vitamin C and 25-hydroxyvitamin D, serum C-reactive protein, parathyroid hormone level (a measure of vitamin D adequacy) and blood histamine will be measured in participating patients prior to starting the treatment and after 7 to 10 days of treatment.
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Within 24 h prior to and within 24 after the 5-10 d treatment course the patient will complete the POMS-B, a validated one-page 30-item questionnaire that assesses mood and energy, and the Distress Thermometer. Patients followed only for the 5-10 d duration of the clinical trial.
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The chart will be reviewed for age, sex, diagnosis, and pertinent lab results.
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After the initial blood sample has been drawn and the questionnaire completed the patient will begin treatment either with vitamin C 500 mg twice daily or vitamin D 5000 IU daily; both vitamins will be prescribed by one of the collaborating physicians without knowledge of the person who recruits, assesses and follows the patient. Treatment assignment will be by coin toss.
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The questionnaire and blood sampling will be repeated after 7 to 10 days of treatment (as determined by feasibility and the situation on the ward) or prior to discharge if discharge is going to occur before the full course of treatment.
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
- Double (Participant, Investigator)
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
- •acutely hospitalized in our hospital
- •mentally competent
- •judged likely to remain in hospital for at least the following 7 days
- •fluent in French or English
排除标准
- •presence of hypercalcemia
- •receiving hemodialysis treatment
- •critically ill
- •unable to take medication by mouth
研究组 & 干预措施
vitamin C
vitamin C 500 mg twice daily
干预措施: vitamin C or vitamin D (Dietary Supplement)
vitamin D
vitamin D 5000 IU daily
干预措施: vitamin C or vitamin D (Dietary Supplement)
结局指标
主要结局
mood
时间窗: prior to and after 5-10 days of treatment
total mood disturbance score on the POMS-B (profile of mood states). Durations of hospital stay are variable and often unpredictable. The intended duration of therapy is 7 to 10 days of treatment, with baseline just prior to starting and outcome measurement recorded just after the final day of therapy. The 7-10 day window is necessary and valid to account for vagaries in duration of hospital stay as well as the interfering effect of weekends when less staffing is available. As in our prior published work, any treatment duration 5 days or longer is included as sufficient.
次要结局
- Blood histamine concentration(prior to and after 5-10 days of treatment)
- distress(prior to and after 5-10 days of treatment)
研究者
John Hoffer
MD
Jewish General Hospital