NCT01630720

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
10 months until next milestone

First Posted

Study publicly available on registry

June 28, 2012

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

3 months

First QC Date

June 21, 2011

Last Update Submit

February 28, 2018

Conditions

Patients With Hypovitaminosis C and DVitamin Deficiencies

Keywords

ascorbic acidcholecalciferolvitamin Cvitamin Dhypovitaminosismooddistress

Outcome Measures

Primary Outcomes (1)

  • mood

    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.

    prior to and after 5-10 days of treatment

Secondary Outcomes (2)

  • Blood histamine concentration

    prior to and after 5-10 days of treatment

  • distress

    prior to and after 5-10 days of treatment

Study Arms (2)

vitamin C

ACTIVE COMPARATOR

vitamin C 500 mg twice daily

Dietary Supplement: vitamin C or vitamin D

vitamin D

ACTIVE COMPARATOR

vitamin D 5000 IU daily

Dietary Supplement: vitamin C or vitamin D

Interventions

vitamin C or vitamin DDIETARY_SUPPLEMENT

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

vitamin Cvitamin D

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (1)

  • 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.

    PMID: 23885048DERIVED

MeSH Terms

Conditions

Avitaminosis

Interventions

Ascorbic AcidVitamin D

Condition Hierarchy (Ancestors)

Deficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesSecosteroidsSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 28, 2012

Study Start

June 1, 2011

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

CA(1)