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Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized. (PNEUMO-VITA-C)

Primary Purpose

Pneumonia With Hospitalized Elderly Patient

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

Vitamin C

Placebo

About this trial

This is an interventional treatment trial for Pneumonia With Hospitalized Elderly Patient focused on measuring Pneumonia, Elderly, Ascorbic acid, Vitamin C, Hospitalized patient

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

people aged ≥ 75 years old
pneumonia's symptoms according to the SPILF (Société de Pathologie Infectieuse de Langue Française) :
- cough
- at least one respiratory sign : dyspnea, chest pain, wheezing, and local signs at the auscultation
- at least one general sign suggesting an infection : fever, sweat, headache, sore joints, common cold
pneumonia's symptoms developed between the admission's date in the unit care and the seventh day included

Exclusion Criteria:

palliative care's patients
patients with deglutition's disorders
patients who can't be on a drip
antibiotherapy since more one day
other concomitant infection(s)
patients who can't make their own transfer 15 days ago
patients who have a NYHA score at IV 15 days ago
patients with contraindication to a vitamin C treatment : hemochromatosis, oxalo-calcic lithiasis antecedent, G6PD deficit (Glucose 6 Phosphate Dehydrogenase), and treatment by Deferoxamine

Sites / Locations

CHU de Bordeaux, Hôpital Saint André

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vitamin C

Placebo

Arm Description

Each patient of this group will be received a direct intravenous injection of 2,5 ml ascorbic acid twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, ascorbic acid's capsules produced by the University Hospital Bordeaux's central pharmacy to keep the double blind way of this study will be given at patient at the morning and at the lunchtime.

Each patient of this group will be received a direct intravenous injection of 2,5 ml NaCl 9% twice a day (at the morning and the lunchtime) from d1 to d2 included. From d3 to d7 included, mannitol's capsules produced by the University Hospital Bordeaux's central pharmacy will be given at patient at the morning and at the lunchtime.

Outcomes

Primary Outcome Measures

Difference in the NYHA score between d-15 and d4 after treatment initiation

The NYHA score d-15 would be noted by medical staff at the inclusion by calling the patient's general practitioner. The NYHA score at d4 will be noted by investigators treating the patient.

Secondary Outcome Measures

The NYHA score at d2 and d7

Dyspnea's visual analogic scale at d2, d4 and d7

Blood saturation without oxygen therapy at d2, d4 and d7

Katz's ADL (Activities Daily Living) score at d2,d4 and d7

Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7

Asthenia's evaluation at d2,d4 and d7

Possibility for the patient to make his or her own transfer at d2,d4 and d7

Morbidity-mortality at d2,d4 and d7

Blood inflammation parameters at d2,d4 and d7

Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7

Vitamin C blood level at d7

Full Information

NCT ID

NCT02186158

First Posted

July 4, 2014

Last Updated

September 14, 2016

Sponsor

University Hospital, Bordeaux

1. Study Identification

Unique Protocol Identification Number

NCT02186158

Brief Title

Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

Acronym

PNEUMO-VITA-C

Official Title

Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Pneumonia is the second common infection and its risk increases for elderly. In this population, it is the first cause of mortality by infections, and source of many complications. Geriatric studies had shown the high prevalence of ascorbic acid 's deficiency, especially in older hospitalized people. It is well known that vitamin C is one of the key of the immune system, it has a scavenger's role in case of aggression like sepsis. A Cochrane database published in 2013 analyzed the impact of vitamin C for preventing and treating pneumonia. Two randomized studies showed a benefit on respiratory symptoms for patients treated by vitamin C, and for one of those studies it was noted a significant reduction of mortality. The main objective of our study is first to determine the impact on respiratory symptoms of an adjuvant treatment by vitamin C for the management of pneumonia in older people hospitalized, and then evaluate its impact on functional status.

Detailed Description

This study is French non-comparative phase II clinical trial, double-blind randomized, with placebo, single-center. One group would be treated the placebo group, and another would receive an adjuvant treatment by vitamin C : 500 mg twice a day by intra-venous way from the first day to the second included, and then 500 mg twice a day by oral way from the third day to the seventh. For each patient, the study's duration is 7 days, which is the mean stay of hospitalization. During those 7 days, we will make clinical exams and blood tests at d0, d2, d4 and d7. The vitamin C blood level will be measured at d0 and d7.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pneumonia With Hospitalized Elderly Patient

Keywords

Pneumonia, Elderly, Ascorbic acid, Vitamin C, Hospitalized patient

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

9 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Vitamin C

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Vitamin C

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Difference in the NYHA score between d-15 and d4 after treatment initiation

Description

The NYHA score d-15 would be noted by medical staff at the inclusion by calling the patient's general practitioner. The NYHA score at d4 will be noted by investigators treating the patient.

Time Frame

4 days after randomisation/treatment initiation

Secondary Outcome Measure Information:

Title

The NYHA score at d2 and d7

Time Frame

2 and 7 days after randomisation/treament initiation

Title

Dyspnea's visual analogic scale at d2, d4 and d7

Time Frame