Vitamin Therapy in JGH Patients

This study has been completed.
Sponsor:
Collaborator:
McGill University
Information provided by (Responsible Party):
John Hoffer, Jewish General Hospital
ClinicalTrials.gov Identifier:
NCT01630720
First received: June 21, 2011
Last updated: June 20, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Acutely Hospitalized Patients at Clinical Risk of Hypovitaminosis C and D
N.B. Vitamin Deficiencies Are Recognized Diseases/Conditions.
Dietary Supplement: vitamin C or D therapy in acutely-hospitalized patients
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin Therapy in JGH Patients

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • mood [ Time Frame: prior to and after 5-10 days of treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Blood histamine concentration [ Time Frame: prior to and after 5-10 days of treatment ] [ Designated as safety issue: No ]
    Blood histamine concentration. 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.

  • distress [ Time Frame: prior to and after 5-10 days of treatment ] [ Designated as safety issue: No ]
    the distress thermometer. 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.


Enrollment: 88
Study Start Date: June 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vitamin C
vitamin C 500 mg twice daily
Dietary Supplement: vitamin C or D therapy in acutely-hospitalized patients
vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days
Active Comparator: vitamin D
vitamin D 5000 IU daily
Dietary Supplement: vitamin C or D therapy in acutely-hospitalized patients
vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630720

Locations
Canada, Quebec
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
McGill University
  More Information

No publications provided by Jewish General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: John Hoffer, MD, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01630720     History of Changes
Other Study ID Numbers: 11-041
Study First Received: June 21, 2011
Last Updated: June 20, 2013
Health Authority: Canada: Health Canada

Keywords provided by Jewish General Hospital:
ascorbic acid
cholecalciferol
vitamin C
vitamin D
hypovitaminosis
mood
distress

Additional relevant MeSH terms:
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Ascorbic Acid
Vitamin D
Vitamins
Antioxidants
Bone Density Conservation Agents
Growth Substances
Micronutrients
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014