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

NCT02186158 | Terminated Phase 2

• 2 other identifiers: CHUBX 2013/092014-000788-42
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia With Hospitalized Elderly Patient

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  4 days after randomisation/treatment initiation

Secondary Outcomes (9)

• The NYHA score at d2 and d7

  2 and 7 days after randomisation/treament initiation

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

  2, 4 and 7 days after randomisation/treament initiation

• Blood saturation without oxygen therapy at d2, d4 and d7

  2, 4 and 7 days after randomisation/treament initiation

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

  2, 4 and 7 days after randomisation/treament initiation

• Asthenia's evaluation at d2,d4 and d7

  2, 4 and 7 days after randomisation/treament initiation

Study Arms (2)

Vitamin C

EXPERIMENTAL

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

PLACEBO COMPARATOR

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

Interventions

Vitamin C DRUG

Vitamin C

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux, Hôpital Saint André

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Pneumonia

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Aurélie LAFARGUE, MD

  University Hospital Bordeaux (France)

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital Bordeaux (France)

  STUDY CHAIR

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: SPONSOR

Study Record Dates

• First Submitted: July 4, 2014
• First Posted: July 10, 2014
• Study Start: February 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 22, 2026

Record last verified: 2016-09

Locations

FR (1)