Protein Supplementation in Thiazide-induced Hyponatremia
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|ClinicalTrials.gov Identifier: NCT02614807|
Recruitment Status : Recruiting
First Posted : November 25, 2015
Last Update Posted : June 17, 2016
|Condition or disease||Intervention/treatment||Phase|
|Hyponatremia Hypertension Blood Pressure||Dietary Supplement: Nepro||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||May 2018|
|Estimated Study Completion Date :||December 2018|
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).
Dietary Supplement: Nepro
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.
- 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.
- Feasibility: recruitment (proportion of patients who are screened and eligible, and proportion eligible who consent) [ Time Frame: 4 weeks ]The proportion of patients who are screened and found to be eligible and the proportion of those eligible who actually consent for the study
- Safety: Tolerability of intervention (proportion of patients who can tolerate the Nepro supplement) [ Time Frame: 2 and 4 weeks ]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.
- Safety: Worsening of hyponatremia (proportion of patients with Sodium < 125 mmol/L at 2 or 4 weeks) [ Time Frame: 2 and 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
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): NCT02614807
|Contact: Marcel Ruzicka, MD PhD||6137388400|
|Contact: Swapnil Hiremath, MD MPH||6137388400 ext 82762|
|Ottawa Hospital Research Institute||Recruiting|
|Ottawa, Ontario, Canada, K1H7W9|
|Contact: Jessica Wagner 6137985555 ext 82514|
|Principal Investigator: Marcel Ruzicka, MD PhD|
|Principal Investigator: Swapnil Hiremath, MD MPH|
|Principal Investigator:||Marcel Ruzicka, MD PhD||Ottawa Hospital Research Institute|