Interest of Ascorbic Acid in the Management of Pneumonia in Elderly People Hospitalized. (PNEUMO-VITA-C)
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ClinicalTrials.gov Identifier: NCT02186158 |
Recruitment Status :
Completed
First Posted : July 10, 2014
Last Update Posted : September 15, 2016
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Condition or disease | Intervention/treatment | Phase |
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Pneumonia With Hospitalized Elderly Patient | Drug: Vitamin C Drug: Placebo | Phase 2 |
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 |

Arm | Intervention/treatment |
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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.
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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.
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Drug: Placebo |
- 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.
- The NYHA score at d2 and d7 [ Time Frame: 2 and 7 days after randomisation/treament initiation ]
- Dyspnea's visual analogic scale at d2, d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
- Blood saturation without oxygen therapy at d2, d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
- 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
- Asthenia's evaluation at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
- 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 ]
- Morbidity-mortality at d2,d4 and d7 [ Time Frame: 2, 4 and 7 days after randomisation/treament initiation ]
- 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
- Vitamin C blood level at d7 [ Time Frame: 7 days after randomisation/treament initiation ]

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Ages Eligible for Study: | 75 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- people aged ≥ 75 years old
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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02186158
France | |
CHU de Bordeaux, Hôpital Saint André | |
Bordeaux, France, 33000 |
Principal Investigator: | Aurélie LAFARGUE, MD | University Hospital Bordeaux (France) | |
Study Chair: | Antoine BENARD, MD | University Hospital Bordeaux (France) |
Responsible Party: | University Hospital, Bordeaux |
ClinicalTrials.gov Identifier: | NCT02186158 |
Other Study ID Numbers: |
CHUBX 2013/09 |
First Posted: | July 10, 2014 Key Record Dates |
Last Update Posted: | September 15, 2016 |
Last Verified: | September 2016 |
Pneumonia Elderly Ascorbic acid Vitamin C Hospitalized patient |
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 |