HealthyPhase 3NCT00509405
Effect of Neutralization of Endogenous Acid Production on BMD and Bone Microarchitectural
A Phase 3 study testing potassium citrate in people with Healthy, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
Trial summary
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y). Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- potassium citrate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 202 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2007to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5
Who cannot join
- Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5)
- Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years
- Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)
- vegetarians
- concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.
- vitamin D deficiency at screening visit
- technical difficulties to delineate bone area of interest during the screening visit
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Medicine, Kantonsspital Bruderholz
Bruderholz/Basel, Basel-Landschaft, CH-4101
About this study
Official title: Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y).
Read the detailed description
We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.
Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
- Conditions
- Healthy
- Being tested
- potassium citrate
- Keywords
- Endogenous acid production, metabolic acidosis, potassium citrate, osteoporosis, sarcopenia, hypertension, Effect of potassium citrate on bone mineral density and bone mass
- Medical subject headings
- Acidosis, Osteoporosis, Sarcopenia, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
potassium citrateDrug
6 times 10 mEq per day, oral for 24 months
| Study group | Role | What they receive |
|---|---|---|
| Potassium citrate | Placebo comparator | Not described Receives: Drug: potassium citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius
Measured: 12 and 24 months
Secondary outcomes (5)
Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure
Measured: 12 and 24 months
effect on skeletal muscle mass and strength
Measured: 12 and 24 months
effect on left ventricular muscle mass
Measured: 24 months
effect on carotid media-intima thickness
Measured: 24 months
Hypoxia-induced endothelial vasorelaxation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kantonsspital Baselland Bruderholz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reto Krapf, Kantonsspital Baselland Bruderholz
- Investigators
- Reto Krapf, MD, Principal investigator, Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00509405
- Sponsor's protocol ID
- 316/06
- Other IDs
- NFP 53: 4053-110259
- Status last verified
- Apr 2012
- First submitted
- 30 Jul 2007
- Last updated
- 24 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone in Humans
- ClinicalTrials.gov ID
- NCT00509405
- Acronym / sponsor ID
- 316/06
- Conditions
- Healthy
- Keywords
- Endogenous acid production, metabolic acidosis, potassium citrate, osteoporosis, sarcopenia, hypertension, Effect of potassium citrate on bone mineral density and bone mass
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- Kantonsspital Baselland BruderholzUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 31 Jul 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: Neutralization of acid production induced by the Western diet with oral administration of potassium citrate increases bone mineral density and bone mass as well as skeletal muscle mass and strength in elderly people (> 65y).
Detailed description
We will perform a prospective, randomized, placebo-controlled trial evaluating the effect of K citrate on bone mineral density, microarchitectural composition of bone,nutritional parameters, lean body mass, parameters of skeletal muscle mass and strength, 24h and exercise induced blood pressure changes in otherwise healthy, elderly ambulatory subjects of both genders.
Potassium citrate (60 mEq) is supplied as tablets with a wax matrix (10 mEq of citrate per tablet) and ingested in three doses/day. All subjects will receive daily oral 500 mg of calcium and 400 IU of vitamin D to ensure adequate calcium and vitamin D supply.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Potassium citrate | Placebo comparator | Drug: potassium citrate |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Men and women, 65 to 80y, tscores at L2-L4 0 to -2.5
Key exclusion criteria (7 listed)
- Treated or necessity to treat low BMD (t-score L2 to L4 <-2.5)
- Any major medical illness that would possibly need hospitalization and/or be followed by foreseeable complications within 12 months and/or have a life-expectancy of less than 5 years
- Stable serum creatinine > 150 umol/l and/or known Type IV renal-tubular acidosis (hyperkalemia)
- vegetarians
- concommitant drug prescriptions: systemic and topical glucocorticoids, systemically acting estrogens (topical allowed): both within the last 6 months. antiosteoporosis drugs: bisphosphoponates, fluoride, calcitonin, all within the previous 12 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| potassium citrate6 times 10 mEq per day, oral for 24 months | Drug | Potassium citrate |
Primary outcome
BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius
Time frame: 12 and 24 months
5 secondary outcomes
Effect on BMD at hip and total body Effect on 24h ambulatory blood pressure
Time frame: 12 and 24 months
effect on skeletal muscle mass and strength
Time frame: 12 and 24 months
effect on left ventricular muscle mass
Time frame: 24 months
effect on carotid media-intima thickness
Time frame: 24 months
Hypoxia-induced endothelial vasorelaxation
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2012.
- check in archive for "essen wir zu sauer"Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reto Krapf, MD principal investigator
Department of Medicine, Kantonsspital Bruderholz, CH-4101 Bruderholz/Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing potassium citrate in people with Healthy, run by Kantonsspital Baselland Bruderholz at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BMD at L2-L4 by DEXA and microarchitectural composition of bone in both tibias and radius (time frame: 12 and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2012.