Vitamin Therapy in JGH Patients

NCT ID: NCT01630720

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2011-09-30

Brief Summary

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.

Detailed Description

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.

Conditions

Patients With Hypovitaminosis C and D; Vitamin Deficiencies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

vitamin C

vitamin C 500 mg twice daily

Group Type: ACTIVE_COMPARATOR

vitamin C or vitamin D

Intervention Type: DIETARY_SUPPLEMENT

vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days

vitamin D

vitamin D 5000 IU daily

Group Type: ACTIVE_COMPARATOR

vitamin C or vitamin D

Intervention Type: DIETARY_SUPPLEMENT

vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days

Interventions

vitamin C or vitamin D

vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• presence of hypercalcemia
• receiving hemodialysis treatment
• critically ill
• unable to take medication by mouth

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

Jewish General Hospital

OTHER

Sponsor Role: lead

Responsible Party

John Hoffer

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Jewish General Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Wang Y, Liu XJ, Robitaille L, Eintracht S, MacNamara E, Hoffer LJ. Effects of vitamin C and vitamin D administration on mood and distress in acutely hospitalized patients. Am J Clin Nutr. 2013 Sep;98(3):705-11. doi: 10.3945/ajcn.112.056366. Epub 2013 Jul 24.

Reference Type: DERIVED

PMID: 23885048 (View on PubMed)

Other Identifiers

11-041

Identifier Type: -

Identifier Source: org_study_id