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

• ClinicalTrials.gov Identifier: NCT02186158
• Recruitment Status: Completed
• First Posted: July 10, 2014
• Last Update Posted: September 15, 2016
• Sponsor: University Hospital, Bordeaux
• Information provided by (Responsible Party): University Hospital, Bordeaux

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.

Condition or disease	Intervention/treatment	Phase
Pneumonia With Hospitalized Elderly Patient	Drug: Vitamin C; Drug: Placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 9 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized.
• Study Start Date: February 2015
• Actual Primary Completion Date: May 2016
• Actual Study Completion Date: May 2016

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin C; 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.	Drug: Vitamin C
Placebo Comparator: Placebo; 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.	Drug: Placebo

Outcome Measures

Primary Outcome Measures :

1. Difference in the NYHA score between d-15 and d4 after treatment initiation [ Time Frame: 4 days after randomisation/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 :

1. The NYHA score at d2 and d7 [ Time Frame: 2 and 7 days after randomisation/treament initiation ]
2. Dyspnea's visual analogic scale at d2, d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
3. Blood saturation without oxygen therapy at d2, d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
4. Katz's ADL (Activities Daily Living) score at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
   Katz's ADL will be calculated by medical trained students or doctors at d2, d4 and d7
5. Asthenia's evaluation at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
6. Possibility for the patient to make his or her own transfer at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
7. Morbidity-mortality at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
8. Blood inflammation parameters at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
   Leukocytes and polynuclear neutrophil 's rates, with C-reactive protein will be measured at d2, d4 and d7
9. Vitamin C blood level at d7 [ Time Frame: 7 days after randomisation/treament initiation ]

Eligibility Criteria

• Ages Eligible for Study: 75 Years and older (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

France

CHU de Bordeaux, Hôpital Saint André

Bordeaux, France, 33000

Sponsors and Collaborators

University Hospital, Bordeaux

Investigators

• Principal Investigator: Aurélie LAFARGUE, MD; University Hospital Bordeaux (France)
• Study Chair: Antoine BENARD, MD; University Hospital Bordeaux (France)

More Information

• Responsible Party: University Hospital, Bordeaux
• ClinicalTrials.gov Identifier: NCT02186158
• Other Study ID Numbers: CHUBX 2013/09
• First Posted: July 10, 2014
• Last Update Posted: September 15, 2016
• Last Verified: September 2016

Keywords provided by University Hospital, Bordeaux:

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

Additional relevant MeSH terms:

Pneumonia; Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Infections; Ascorbic Acid; Vitamins; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Antioxidants; Molecular Mechanisms of Pharmacological Action; Protective Agents