Patients With Hypovitaminosis C and D Clinical Trial
Official title:
Vitamin Therapy in JGH Patients
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.
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:
1. Mentally competent patients fluent in English or French admitted to the surgical or
medical units of the hospital will be offered participation.
2. 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.
3. 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.
4. The chart will be reviewed for age, sex, diagnosis, and pertinent lab results.
5. 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.
7. 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.
8. Neither the patient nor the person who administers the questionnaires will know which
patient receives vitamin C or D. The vitamin D and C tablets are distinguishable, so patients
motivated to do so could figure out which vitamin they are being prescribed. Since both
treatments are being used to correct deficiency diseases which are strongly suspected to
affect mood, neither patients, nurses, nor the students following the patients have no basis
to anticipate that one treatment will improve their mood more than the other one.
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