Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate
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|ClinicalTrials.gov Identifier: NCT02743650|
Recruitment Status : Recruiting
First Posted : April 19, 2016
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease||Dietary Supplement: Sodium bicarbonate||Early Phase 1|
CKD affects 25 million Americans and the risks of cardiovascular morbidity, hospitalizations, and death are substantially higher for people with CKD. Furthermore, 6% of the total Medicare budget is spent on 600,000 people with end-stage renal disease. Thus, CKD is highly prevalent, associates with poor outcomes, and is a tremendous financial burden to society.
Apart from treating hypertension and diabetes, there are no therapies that prevent CKD. However, results from two studies have found that low serum bicarbonate levels increase risk of developing CKD, which suggests that normalizing low serum bicarbonate may prevent CKD.
One way to raise low serum bicarbonate is by taking sodium bicarbonate. Whether sodium bicarbonate, which is commonly prescribed to raise low serum bicarbonate in people with CKD, can raise low bicarbonate in people without CKD is uncertain because the reason bicarbonate is low in people without CKD is unclear. This is because low bicarbonate by itself cannot distinguish whether the acid-base abnormality is primary metabolic acidosis or respiratory alkalosis. The former process is readily corrected with alkali. However, the administration of alkali in the latter situation may not raise bicarbonate concentration.
Therefore, the purpose of this pilot study is to determine whether oral sodium bicarbonate can raise low serum bicarbonate in people without renal disease.
The study is a single-arm open label study of 15 individuals without CKD with low serum bicarbonate concentration. The study duration is 10 weeks. After completing the baseline visit, participants will take oral sodium bicarbonate (initial dose level: 0.3 milliequivalents per kilogram per day (mEq/kg/d) for 6 weeks (On-treatment period), followed by a 4 week Off-treatment period. Serum concentrations of sodium bicarbonate will be tested during the treatment period, at the end of the On-treatment period (Week 6) and at the end of the Off-treatment period (Week 10).
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pilot Study of Sodium Bicarbonate in Generally Healthy People With Low Bicarbonate|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Sodium Bicarbonate
All participants will receive oral sodium bicarbonate for 6 weeks (On-treatment period). After the 6 week visit, participants will stop taking sodium bicarbonate and return for a final visit 4 weeks later (Off-treatment period).
The initial dose of sodium bicarbonate prescribed is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d. Half the dose will be taken by mouth in the morning and the other half in the evening.
Dietary Supplement: Sodium bicarbonate
The initial dose of sodium bicarbonate is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d.
- Change in serum bicarbonate concentration from baseline to 6 weeks [ Time Frame: Baseline and 6 weeks ]Comparison of pre-intervention serum bicarbonate levels to week 6 levels following treatment with oral sodium bicarbonate.
- Change in serum bicarbonate concentration after 4 weeks of stopping sodium bicarbonate treatment [ Time Frame: Baseline, 6 weeks and 10 weeks ]Comparison of serum bicarbonate levels four weeks after discontinuing oral sodium bicarbonate treatment to pre-intervention (baseline) and immediate post-treatment (week 6) serum bicarbonate levels.
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): NCT02743650
|Contact: Kalani L Raphael, MD||801-582-1565 ext email@example.com|
|Contact: Jennifer L Zitterkophfirstname.lastname@example.org|
|United States, Utah|
|VA Salt Lake City Healthcare System||Recruiting|
|Salt Lake City, Utah, United States, 84112|
|Contact: Kalani L Raphael, MD 801-582-1565 ext 1794 email@example.com|
|Contact: Jennifer L Zitterkoph 801-585-1897 firstname.lastname@example.org|
|Principal Investigator: Kalani L Raphael, MD|
|Principal Investigator:||Kalani L Raphael, MD||VA Salt Lake City Healthcare System|