HyponatremiaNCT02614807
Protein Supplementation in Thiazide-induced Hyponatremia
A study testing Nepro in people with Hyponatremia and Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
High blood pressure is very common among elderly Canadians. Clinical trials show clear benefit from lowering blood pressure in hypertensive elderly patients. These trials also demonstrate safety for several classes of blood pressure lowering drugs including water pills. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hyponatremia, Hypertension, Blood Pressure
- What is being tested?
- Nepro
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2016to May 2018
- 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
- Elderly (>65 years old)
- with diagnosed hypertension (HTN) treated with thiazide (hydrochlorothiazide) or thiazide-like (chlorthalidone and indapamide) diuretic and
- mild to moderate hyponatremia (Plasma sodium concentration 125-133 mmol/L).
Who cannot join
- Pregnancy
- estimated glomerular filtration rate (eGFR) <45 ml/min/1.75 m2,
- Other causes of hyponatremia (liver cirrhosis, uncontrolled hypothyroidism, adrenal insufficiency)
- unable to provide informed consent;
- patients with generalized volume overload who may require immediate changes in diuretic therapy (at the discretion of treating HTN specialist);
- patients taking drugs which may interfere with urinary sodium excretion (such as carbamazepine, loop diuretics, potassium sparing diuretics, mineralocorticoid and glucocorticosteroids, selective serotonin receptor inhibitors, tricyclic antidepressants, amiodarone, and lithium);
- patients with moderate to severe hyponatremia (Plasma sodium concentration < 125 mmol/L) who may require immediate discontinuation of the thiazide diuretic .
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thiazide Diuretic-caused Hyponatremia in the Elderly Hypertensive: Will a Bottle of Nepro a Day Keep Hyponatremia and the Doctor Away? A Proof-of-Concept Trial
High blood pressure is very common among elderly Canadians. Clinical trials show clear benefit from lowering blood pressure in hypertensive elderly patients. These trials also demonstrate safety for several classes of blood pressure lowering drugs including water pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt coupled with high water intake. A standard approach to treatment is lacking since higher salt intake may worsen hypertension, and lower water and higher protein intake is difficult to understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in potassium and sodium. It is used frequently as a dietary supplement in patients with kidney disease specifically for low sodium and high protein content. The high protein content in Nepro can help the kidney get rid of excess water, and the low sodium and potassium content will make this a safe option to use. Hence investigators propose a proof-of-concept trial on an easy to understand and administer, and relatively affordable solution to this issue. It could be summarized in one sentence: "Will a bottle of Nepro a day keep thiazide-caused hyponatremia and the doctor away?"
- Conditions
- Hyponatremia, Hypertension, Blood Pressure
- Being tested
- Nepro
- Keywords
- Dietary Supplement
- Medical subject headings
- Hyponatremia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeproDietary supplement
The intervention is a dietary protein supplement. In the elderly hypertensive patient (assuming body weight of 70 kg) with mild to moderate hyponatremia free water excess is around 2.5 L. One bottle of Nepro/day will generate about 120 mosm to be excreted via urine. Given limited and mostly fixed urinary dilution and concentration between 300 and 800 mosm/L in the elderly and very elderly, one bottle of Nepro a day will result in an extra 400 ml of urine for a net loss of 163 ml of free water. Thus over the period of 2 to 4 weeks the calculated free water excess should be completely eliminated.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | All recruited patients will receive a standard endorsement of lower fluid intake (<1.5 Litres/day) by a hypertension nurse and physician and an additional treatment consisting of a bottle (237 ml) of Nepro (a low sodium, low potassium content protein supplement) a day (supply for 4 weeks will be provided). Receives: Dietary Supplement: Nepro |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Correction of Hyponatremia (Serum Sodium > 133 mmol/L or reduction of deficit by 50%)
The cumulative proportion of participants whose serum sodium either normalizes (>133 mmol/L) by 4 weeks or who exhibit a decrease in deficit by 50% compared to baseline level.
Measured: 4 weeks
Secondary outcomes (3)
Feasibility: recruitment (proportion of patients who are screened and eligible, and proportion eligible who consent)
The proportion of patients who are screened and found to be eligible and the proportion of those eligible who actually consent for the study
Measured: 4 weeks
Safety: Tolerability of intervention (proportion of patients who can tolerate the Nepro supplement)
The proportion of patients who tolerate the Nepro supplement for the duration of the study, and who are able to comply with the daily supplementation for the period of study.
Measured: 2 and 4 weeks
Safety: Worsening of hyponatremia (proportion of patients with Sodium < 125 mmol/L at 2 or 4 weeks)
In addition, the proportion of patients who might have a worsening of hyponatremia (plasma sodium < 125 mmol/L) either at 2 weeks or at 4 weeks, which will result in immediate discontinuation of the thiazide diuretic will also be measured and reported
Measured: 2 and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJun 2016
- Primary completionMay 2018
- Study completionMay 2018
Why it stopped: Difficult Recruitment
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.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcel Ruzicka, MD PhD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614807
- Sponsor's protocol ID
- 201504516
- Status last verified
- Sep 2018
- First submitted
- 21 Oct 2015
- Last updated
- 10 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ruzicka M, McCormick B, Magner P, Ramsay T, Edwards C, Bugeja A, Hiremath S. Thiazide diuretic-caused hyponatremia in the elderly hypertensive: will a bottle of Nepro a day keep hyponatremia and the doctor away? Study protocol for a proof-of-concept feasibility trial. Pilot Feasibility Stud. 2018 Apr 6;4:71. doi: 10.1186/s40814-018-0263-y. eCollection 2018.
PubMed 29636984
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thiazide Diuretic-caused Hyponatremia in the Elderly Hypertensive: Will a Bottle of Nepro a Day Keep Hyponatremia and the Doctor Away? A Proof-of-Concept Trial
- ClinicalTrials.gov ID
- NCT02614807
- Acronym / sponsor ID
- 201504516
- Conditions
- Hyponatremia, Hypertension, Blood Pressure
- Keywords
- Dietary Supplement
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Difficult Recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jun 2016
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 25 Nov 2015 (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.
High blood pressure is very common among elderly Canadians. Clinical trials show clear benefit from lowering blood pressure in hypertensive elderly patients. These trials also demonstrate safety for several classes of blood pressure lowering drugs including water pills. However, water pills (thiazide diuretics) used for treatment of hypertension, can cause low sodium (hyponatremia), a significant clinical problem mainly among elderly and very elderly. Causes are age related decrease in kidneys' ability to get rid of water and low salt coupled with high water intake. A standard approach to treatment is lacking since higher salt intake may worsen hypertension, and lower water and higher protein intake is difficult to understand and actually implement. 'Nepro' is a nutritional drink high in protein, and low in potassium and sodium. It is used frequently as a dietary supplement in patients with kidney disease specifically for low sodium and high protein content. The high protein content in Nepro can help the kidney get rid of excess water, and the low sodium and potassium content will make this a safe option to use. Hence investigators propose a proof-of-concept trial on an easy to understand and administer, and relatively affordable solution to this issue. It could be summarized in one sentence: "Will a bottle of Nepro a day keep thiazide-caused hyponatremia and the doctor away?"
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Dietary Supplement: NeproAll recruited patients will receive a standard endorsement of lower fluid intake (<1.5 Litres/day) by a hypertension nurse and physician and an additional treatment consisting of a bottle (237 ml) of Nepro (a low sodium, low potassium content protein supplement) a day (supply for 4 weeks will be provided). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Elderly (>65 years old)
- with diagnosed hypertension (HTN) treated with thiazide (hydrochlorothiazide) or thiazide-like (chlorthalidone and indapamide) diuretic and
- mild to moderate hyponatremia (Plasma sodium concentration 125-133 mmol/L).
Key exclusion criteria (7 listed)
- Pregnancy
- estimated glomerular filtration rate (eGFR) <45 ml/min/1.75 m2,
- Other causes of hyponatremia (liver cirrhosis, uncontrolled hypothyroidism, adrenal insufficiency)
- unable to provide informed consent;
- patients with generalized volume overload who may require immediate changes in diuretic therapy (at the discretion of treating HTN specialist);
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 |
|---|---|---|
| NeproThe intervention is a dietary protein supplement. In the elderly hypertensive patient (assuming body weight of 70 kg) with mild to moderate hyponatremia free water excess is around 2.5 L. One bottle of Nepro/day will generate about 120 mosm to be excreted via urine. Given limited and mostly fixed urinary dilution and concentration between 300 and 800 mosm/L in the elderly and very elderly, one bottle of Nepro a day will result in an extra 400 ml of urine for a net loss of 163 ml of free water. Thus over the period of 2 to 4 weeks the calculated free water excess should be completely eliminated. | Dietary supplement | Intervention |
Primary outcome
Efficacy: Correction of Hyponatremia (Serum Sodium > 133 mmol/L or reduction of deficit by 50%)
Time frame: 4 weeks
The cumulative proportion of participants whose serum sodium either normalizes (>133 mmol/L) by 4 weeks or who exhibit a decrease in deficit by 50% compared to baseline level.
3 secondary outcomes
Feasibility: recruitment (proportion of patients who are screened and eligible, and proportion eligible who consent)
Time frame: 4 weeks
Safety: Tolerability of intervention (proportion of patients who can tolerate the Nepro supplement)
Time frame: 2 and 4 weeks
Safety: Worsening of hyponatremia (proportion of patients with Sodium < 125 mmol/L at 2 or 4 weeks)
Time frame: 2 and 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2018.
- Background: PubMed 29636984Ruzicka M, McCormick B, Magner P, Ramsay T, Edwards C, Bugeja A, Hiremath S. Thiazide diuretic-caused hyponatremia in the elderly hypertensive: will a bottle of Nepro a day keep hyponatremia and the doctor away? Study protocol for a proof-of-concept feasibility trial. Pilot Feasibility Stud. 2018 Apr 6;4:71. doi: 10.1186/s40814-018-0263-y. eCollection 2018.
- Individual participant dataSharing planned: Undecided
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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.
Marcel Ruzicka, MD PhD principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nepro in people with Hyponatremia and Hypertension, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 10 Sep 2018. 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 Canada. 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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy: Correction of Hyponatremia (Serum Sodium > 133 mmol/L or reduction of deficit by 50%) (time frame: 4 weeks). 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 NCT02614807, 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 10 Sep 2018.