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| Tracking Information | |||||
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| First Received Date ICMJE | July 30, 2007 | ||||
| Last Updated Date | July 30, 2007 | ||||
| Start Date ICMJE | July 2007 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
BMD at L2-L4 by DEXA microarchitectural composition of bone in both tibias and radius [ Time Frame: 12 and 24 months ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effect of Neutralization of Endogenous Acid Production on Bone Mineral Density and Microarchitectural Composition of Bone | ||||
| Official Title ICMJE | |||||
| Brief 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). |
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| 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. |
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| Study Phase | Phase III | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: potassium citrate | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 140 | ||||
| Estimated Completion Date | March 2010 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 65 Years to 80 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Switzerland | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00509405 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | 316/06, NFP 53: 4053-110259 | ||||
| Study Sponsor ICMJE | Kantonsspital Bruderholz | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Kantonsspital Bruderholz | ||||
| Verification Date | July 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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