Hypertension
Conditions
Keywords
Salt sensitivity of Blood Pressure
Brief summary
The purpose of this study is to determine if the drug Celebrex changes the way the kidney gets rid of salt and maintains blood pressure.
Detailed description
There have been many studies done with analgesics such as acetaminophen and non-steroidal anti-inflammatory drugs; however it is not understood how blood pressure changes while using Celebrex. The study hypothesis is that Celebrex will increase salt sensitivity of blood pressure.
Interventions
Celecoxib (Celebrex) was administered at 100 mg, twice per day for each day of sodium diet
OTHERPlacebo
Placebo pill taken twice per day on each day of the diet
Sponsors
Christiana Care Health Services
University of Delaware
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
22 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy men and women
Exclusion criteria
* history of heart disease * have had heart surgery * high blood pressure * diabetes * cancer * any other disease such as kidney or neurological diseases * taking medications such as aspirin or medicines for your heart or blood pressure * have asthma or are allergic to sulfa drugs * body mass index greater than 30 * use tobacco * pregnant * women using oral contraceptives or hormone replacement therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Arterial Pressure | 24 hours | Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urinary Sodium Excretion | 24 hour | Urine collected over 24 hour period on last day of each different sodium diet |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Celebrex, High Sodium Each subject completes a normal sodium diet (3 days), a high salt diet (7 days), and a low salt diet (7 days) while taking either a placebo or celebrex (each trial is 17 days long). Each subject completes 2 full 17 day trials (one month 'washout' between each trial); one time taking the placebo and one taking celebrex (randomized). | 3 |
| Celebrex, Low Sodium 100 mg Celebrex, twice per day for 7 days on low sodium diet | 3 |
| Placebo, Low Sodium Placebo pill taken twice per day over the course of the diet | 3 |
| Placebo, High Sodium Placebo pill taken twice per day over the course of the diet | 3 |
| Total | 12 |
Baseline characteristics
| Characteristic | Celebrex, Low Sodium | Placebo, Low Sodium | Celebrex, High Sodium | Placebo, High Sodium | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 3 Participants | 3 Participants | 3 Participants | 12 Participants |
| Age Continuous | 35 years STANDARD_DEVIATION 2 | 35 years STANDARD_DEVIATION 2 | 35 years STANDARD_DEVIATION 2 | 35 years STANDARD_DEVIATION 2 | 35 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 3 participants | 3 participants | 3 participants | 3 participants | 12 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 3 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 | 0 / 3 | 0 / 3 | 0 / 3 |
Outcome results
Primary
Mean Arterial Pressure
Blood pressure was measured on the last day of each 7 day sodium diet for 24 hours using an ambulatory blood pressure monitor
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celebrex, Low Sodium Diet | Mean Arterial Pressure | 88 mm Hg | Standard Error 2 |
| Celebrex, High Sodium Diet | Mean Arterial Pressure | 87 mm Hg | Standard Error 2 |
| Placebo, Low Sodium Diet | Mean Arterial Pressure | 87 mm Hg | Standard Error 2 |
| Placebo, High Sodium Diet | Mean Arterial Pressure | 87 mm Hg | Standard Error 2 |
Secondary
Urinary Sodium Excretion
Urine collected over 24 hour period on last day of each different sodium diet
Time frame: 24 hour
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Celebrex, Low Sodium Diet | Urinary Sodium Excretion | 17 mmol Na+/24 hr | Standard Error 7 |
| Celebrex, High Sodium Diet | Urinary Sodium Excretion | 281 mmol Na+/24 hr | Standard Error 27 |
| Placebo, Low Sodium Diet | Urinary Sodium Excretion | 14 mmol Na+/24 hr | Standard Error 3 |
| Placebo, High Sodium Diet | Urinary Sodium Excretion | 253 mmol Na+/24 hr | Standard Error 10 |