HyponatremiaNATRIPHARNCT01212211
Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
A study testing change in drug therapy in people with Hyponatremia, run by University Hospital, Caen at 1 site in France.
Trial summary
Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown. Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hyponatremia
- What is being tested?
- change in drug therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2010to May 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patient over 65 years Resident of dependent elderly
- Plasma sodium <135 mmol / l less than a week, confirming earlier hyponatremia within a week to three month agreement given after patient information
Who cannot join
- Venous system does not allow sampling - Patient not taking medication-Dementia
Trial locations and contacts
1 site in 1 country.
About this study
Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown.
Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit.
Read more
Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion.
Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).
- Conditions
- Hyponatremia
- Being tested
- change in drug therapy
- Keywords
- Hyponatremia; Sodium level, Falls, Gait, elderly
- Medical subject headings
- Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
change in drug therapyOther
Change in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists
| Study group | Role | What they receive |
|---|---|---|
| change in drug therapy | Experimental | Change in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists Receives: Other: change in drug therapy |
| reference | No intervention | drug treatment of ten patients will remain unchanged during the three months of inclusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)
Measured: Fourth week
Secondary outcomes (1)
Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls
Changes in serum sodium weekly S1, S2, S3 - Evolution of the score evaluation of postural control: the Timed Up and Go test (TUG) between therapeutic intervention and S4-comparison of the number of falls between the period three months before and three months after surgery Medical Decision to three months whether to maintain the drug therapy changed
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startDec 2010
- Primary completionJan 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HyponatremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Blandine De la Gastine, MD, Principal investigator, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212211
- Sponsor's protocol ID
- 2010-A00778-31
- Acronym
- NATRIPHAR
- Status last verified
- May 2012
- First submitted
- 10 Sep 2010
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Peyro Saint Paul L, Martin J, Gaillard C, Mosquet B, Coquerel A, de la Gastine B. [Moderate potentially drug-induced hyponatremia in older adults: benefit in drug reduction]. Therapie. 2013 Nov-Dec;68(6):341-6. doi: 10.2515/therapie/2013058. Epub 2013 Nov 11. French.
PubMed 24246119
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hyponatremia in the Elderly: Benefit From a Change in Drug Therapy?
- ClinicalTrials.gov ID
- NCT01212211
- Acronym / sponsor ID
- NATRIPHAR / 2010-A00778-31
- Conditions
- Hyponatremia
- Keywords
- Hyponatremia; Sodium level, Falls, Gait, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mild hyponatremia is the commonest electrolyte imbalance in the older population. Recently, association between hyponatremia and bone fractures in the ambulatory elderly has been shown.
Mild chronic hyponatremia is causing falls and lead to hospitalisation because of attention deficit.
Symptoms related to hyponatremia can be very subtle and difficult to detect clinically. Twenty elderly patients, retirement homes residents, with serum sodium < 135mEq/L will be included. They will be randomised. The physician will review the drug treatment of ten patients in coordination with the opinion of pharmacologists. Drug treatment for ten other patients wil remained unchanged during the three months of inclusion.
Useful elements of the medical records of patients randomized to the experimental arm will be forwarded to the Pharmacovigilance Regional Center for opinion pharmacologist. The notice, subject to the attention of physician of retirement homes, give rise to a therapeutic approach towards the patient. It will be followed by weekly monitoring of serum sodium for 4 weeks to evaluate the impact of the intervention. Thus, the effectiveness of medical intervention will be evaluated by an objective biological criteria: serum sodium in the fourth week. Secondary endpoints will evaluate the duration of normalization of serum sodium and check the interest of correcting hyponatremia to improve postural capacities and eventually reduce the number of falls in the medium term (three months).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| change in drug therapy | Experimental | Other: change in drug therapyChange in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists |
| reference | No intervention | –drug treatment of ten patients will remain unchanged during the three months of inclusion |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Patient over 65 years Resident of dependent elderly
- Plasma sodium <135 mmol / l less than a week, confirming earlier hyponatremia within a week to three month agreement given after patient information
Key exclusion criteria (1 listed)
- Venous system does not allow sampling - Patient not taking medication-Dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| change in drug therapyChange in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists | Other | change in drug therapy |
Primary outcome
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly
Time frame: Fourth week
Normalization serum sodium between S0 and S4 (4 weeks after medical intervention)
1 secondary outcome
Normalization of serum sodium-Evaluate the impact on the deficit postural S4-Evaluate the impact on the occurrence of falls
Time frame: three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Results publication: PubMed 24246119Peyro Saint Paul L, Martin J, Gaillard C, Mosquet B, Coquerel A, de la Gastine B. [Moderate potentially drug-induced hyponatremia in older adults: benefit in drug reduction]. Therapie. 2013 Nov-Dec;68(6):341-6. doi: 10.2515/therapie/2013058. Epub 2013 Nov 11. French.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blandine De la Gastine, MD principal investigator
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing change in drug therapy in people with Hyponatremia, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the benefit of a change of drug therapy following a review pharmacologist on the increase in serum sodium in elderly (time frame: Fourth week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212211, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026.