The Effects of Dietary Nitrate in Patients With Hypertensive Kidney Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGødstrup Hospital
About this trial
The study aims to study the effects of diatery nitrate in patients with hypertension and hypertensive kidney injury.
The study is a randomized, placebo-controlled, double-blinded crossover trial. 14-20 patients with hypertension and CKD I-III will be randomized to receive either nitrate or placebo delivered in the form of beetroot juice.
Effect variables will be measured before and after a 2 week treatment. After a washout period of 14 days, the subjects are crossed over to the opposite treatment.
The study is terminated by measuring effect variables after the second treatment period.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hypertension, treated with a maximum of 2 antihypertensive drugs and unattended office BP < 150/95 mmHg at the screening visit, or newly diagnosed without antihypertensive treatment by 24-hour BP or home BP measurement (above 130/80 or 135/85 respectively), and unattended office BP < 160/100 mmHg.
CKD I-III based on hypertensive kidney injury. Patients, who previously met the criteria for CKD I within the last 5 years, but no longer has proteinuria after relevant treatment, can also be included. Diagnosis of CKD I can be based on eGFR and either urine albumin/creatine ration or urine-dipstick test with presence of protein.
Albumin/creatinine ratio < 500 mg/g
eGFR > 30 ml/min/1,73m2
Disqualifiers
• Diagnosis of heart failure, NYHA II-IV
Diagnosis of liver failure
Diabetes mellitus (all types)
Current malignant disease (other than non-melanoma skin cancer)
Trial design
Design model
Crossover
Treatments tested in this trial
Beetroot Juice - Active
Dietary supplementIntervention is beetroot juice ("Beet It concentrated beetroot juice shots", James White Drinks Ltd, Ipswich, England) The nitrate content of the juice is standardized. The dose of nitrate will be 70 ml/day corresponding to intake of 6.5 mmol/400 mg of nitrate.
Beetroot juice placebo
Dietary supplementThe placebo beetroot juice is a corresponding nitrate free beetroot juice, obtained from the manufacturer ("Beet It nitrate depleted shots", James White Drinks Ltd, Ipswich, England.). The placebo juice appears identical to the nitrate containing juice regarding color and taste.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Beetroot juice (active)Active comparator 1 intervention
Group B: Beetroot juice (placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in 24 h systolic blood pressure
Measured by Mobiograph
Time frame
Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)Secondary outcomes
1
Diastolic blood pressure
Mobil graph with 24 h measurments
Time frame
Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)2
Heart rate
Mobil graph with 24 h measurment
Time frame
Measured on 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)3
Pulsewave velocity
Mobil graph with 24 h measurment
Time frame
Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)4
Augmentation index
Mobilograph with 24 h measurment
Time frame
Measured on day 1 and day 15 of the intervention period (This represents baseline and after conclusion of each intervention period)Sponsors and contacts
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Source ClinicalTrials.gov