NCT02078908

Brief 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. 1.increases urinary sodium excretion and renal filtration rate
  2. 2.lowers blood pressure, central as well as peripheral
  3. 3.affects vasoactive hormones
  4. 4.it is possible to establish a dose that affects the renal function with only minor effect on the blood pressure.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Sep 2013

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
6 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

October 9, 2014

Status Verified

October 1, 2014

Enrollment Period

9 months

First QC Date

September 19, 2013

Last Update Submit

October 8, 2014

Conditions

Healthy

Keywords

Central blood pressurePeripheral (brachial) blood pressureRenal variablesVasoactive hormonesPharmacologyPharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Fractional urinary sodium excretion

    One day

Secondary Outcomes (18)

  • Nitrite clearance

    One day

  • Nitrate clearance

    One day

  • Glomerular filtration rate

    One day

  • Proximal sodium transport

    One day

  • Free water clearance

    One day

  • +13 more secondary outcomes

Study Arms (4)

40 micrograms sodium nitrite

ACTIVE COMPARATOR

Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour

Drug: Sodium nitrite, 40 micrograms/kg/hour

120 micrograms sodium nitrite

ACTIVE COMPARATOR

Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour

Drug: Sodium nitrite, 120 micrograms/kg/hour

240 micrograms sodium nitrite

ACTIVE COMPARATOR

Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour

Drug: Sodium nitrite, 240 micrograms/kg/hour

Placebo

PLACEBO COMPARATOR

Continuous 2 hour infusion of sodium chloride, 25 ml/hour

Drug: Placebo

Interventions

Sodium nitrite, 40 micrograms/kg/hourDRUG

Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour

Also known as: NaNO2, ATC V03AB08, EV substance code: SUB15308MIG, CAS15 number: 7632-00-0
40 micrograms sodium nitrite
Sodium nitrite, 120 micrograms/kg/hourDRUG

Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour

Also known as: NaNO2, ATC V03AB08, EV substance code: SUB15308MIG, CAS15 number: 7632-00-0
120 micrograms sodium nitrite
Sodium nitrite, 240 micrograms/kg/hourDRUG

Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour

Also known as: NaNO2, ATC V03AB08, EV substance code: SUB15308MIG, CAS15 number: 7632-00-0
240 micrograms sodium nitrite
PlaceboDRUG

Continuous 2 hour infusion of sodium chloride, 25 ml/hour

Also known as: Sodium chloride
Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 18,5-30 kg/m2
  • Women must use safe contraception

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medical Research, Regional Hospital Holstebro

Holstebro, 7500, Denmark

Location

MeSH Terms

Interventions

Sodium NitriteSodium Chloride

Intervention Hierarchy (Ancestors)

NitritesNitrous AcidNitrogen CompoundsInorganic ChemicalsSodium CompoundsChloridesHydrochloric AcidChlorine Compounds

Study Officials

  • Jesper N Bech, MD, PhD

    Regional Hospital Holstebro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chief physician, PhD

Study Record Dates

First Submitted

September 19, 2013

First Posted

March 5, 2014

Study Start

September 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

October 9, 2014

Record last verified: 2014-10

Locations

DK(1)