Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04755400
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
2021-02-03
Brief Title:
The Effect of Orally Administrated Nitrate on Renal Parameters and Systemic Haemodynamics
Sponsor:
Frank Mose
Organization:
Region MidtJylland Denmark
Study Overview
Official Title:
The Effect of Orally Administrated Nitrate on Renal Parameters and Systemic Haemodynamics in a Randomized Placebo Controlled Crossed Over Study on Healthy Subjects
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
APNI
Brief Summary:
Treatment with nitrate has shown to lower blood pressure in both healthy subjects and hypertensive patientsBeside this nitrate have also shown to decrease arterial stiffness and improve endothelial functionBut the effect of nitrate on renal blood flow kidney function water and salt balance and vasoactive hormones is still unclear
Therefore the purpose of this study is to investigate the effect of orally administered nitrate on these parameters
This will be done in a double-blinded placebo-controlled crossover study 20 healthy subjects will be treated in a randomized order with both potassium nitrate and placebo separated by at least 4 weeks wash-out
Therefore the purpose of this study is to investigate the effect of orally administered nitrate on these parameters
This will be done in a double-blinded placebo-controlled crossover study 20 healthy subjects will be treated in a randomized order with both potassium nitrate and placebo separated by at least 4 weeks wash-out
Detailed Description:
Inorganic nitrate reduces blood pressure and improves endothelial function in both healthy subjects and hypertensive patients
This effect is thought to be caused through bioconversion to nitric oxide Thus improving risk factors of cardiovascular decease by increasing vasodilatation salt regulation and vasoactive hormonesThe purpose of this study is to investigate the effect of inorganic nitrate on kidney function hormones and circulation which is still unknown
The effect of 4 days treatment with 24 mmol potassium nitrate capsules on heart rate blood pressure vasoactive hormones and urinary excretion of sodium and water will be measured in a randomized placebo controlled double blinded crossover study in 20 healthy subjects Each subject attends 2x2 examination days at least 4 weeks apart The examination days are divided into 8 clearance periods of 30 min each The first 3 are baseline periods and in period 4 1 Liter of saline is administered to detect any difference in renal parameters after NaCl load
If inorganic nitrate supplementation is found to lower blood pressure in addition to favorable renal effects it could lead to changes in the general treatment of high blood pressure and cardiovascular disease
This effect is thought to be caused through bioconversion to nitric oxide Thus improving risk factors of cardiovascular decease by increasing vasodilatation salt regulation and vasoactive hormonesThe purpose of this study is to investigate the effect of inorganic nitrate on kidney function hormones and circulation which is still unknown
The effect of 4 days treatment with 24 mmol potassium nitrate capsules on heart rate blood pressure vasoactive hormones and urinary excretion of sodium and water will be measured in a randomized placebo controlled double blinded crossover study in 20 healthy subjects Each subject attends 2x2 examination days at least 4 weeks apart The examination days are divided into 8 clearance periods of 30 min each The first 3 are baseline periods and in period 4 1 Liter of saline is administered to detect any difference in renal parameters after NaCl load
If inorganic nitrate supplementation is found to lower blood pressure in addition to favorable renal effects it could lead to changes in the general treatment of high blood pressure and cardiovascular disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None