The Effect of Sodium Nitrite on Renal Function and Blood Pressure in Healthy Humans. A Dose-response Study

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of different doses of sodium nitrite infusion in 12 healthy subjects. The effects on renal handling of nitrite, nitrate, sodium and water, plasma concentrations of vasoactive hormones, peripheral (brachial) and central blood pressure will be evaluated.

Hypothesis

Sodium nitrite infusion

1. increases urinary sodium excretion and renal filtration rate

2. lowers blood pressure, central as well as peripheral

3. affects vasoactive hormones

4. it is possible to establish a dose that affects the renal function with only minor effect on the blood pressure.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Erling Bjerregaard Pedersen

Criteria

Inclusion Criteria:

• BMI 18,5-30 kg/m2

• Women must use safe contraception

Exclusion Criteria:

• Tobacco smoking, medicine or substance abuse

• Weekly consumption of more than 21 standard drinks of alcohol for men and 14 standard drinks of alcohol for women (1 danish standard drink equals 12 grams of alcohol)

• Medical treatment in the last 2 weeks except for contraception

• Pregnancy or nursing

• Diabetes mellitus

• estimated glomerular filtration rate (eGFR) < 60 ml/min

• neoplasm

• clinically significant heart, lung, liver, kidney, metabolic og neurologic disease

• clinically significant findings in screening blood samples, urine sample or ECG

• Office blood pressure > 140/90 mmHg

• Blood donation within 1 month of the first day of investigation