Status:
COMPLETED
The Effect of Potassium Bicarbonate on Bone and Several Physiological Systems During Immobilisation
Lead Sponsor:
DLR German Aerospace Center
Collaborating Sponsors:
University of Trieste
University of Aarhus
Conditions:
Bone Diseases, Metabolic
Acid-Base Imbalance
Eligibility:
MALE
20-45 years
Phase:
NA
Brief Summary
Mainly due to the absence of gravitational forces in weightlessness, astronauts suffer from an increased bone loss- negatively affecting health and vitality during a mission. The development of effect...
Detailed Description
Astronauts in space suffer from an increased bone loss which is mainly related to the absence of gravitational forces. This increased bone reduction is accompanied by an higher concentration of calciu...
Eligibility Criteria
Inclusion
- healthy male subjects
- age: 20- 45
- weight 65- 85 kg
- height: 158- 190 cm
- BMI 20- 26 kg/m2
- no high performance sports
- non- smoking (minimum 6 months prior to study start)
- willing to complete both parts of the study
- presentation of social security and criminal record
- successful completion of medical and psychological screening
- signed informed consent
Exclusion
- drugs- and alcohol abuse
- antiinflammatory drugs taken during the study
- vegetarianism, veganism
- migraine
- psychical illness in the past
- claustrophobia
- hiatal hernia
- gastroesophageal reflux
- diabetes mellitus
- Rheumatic disease
- muscle or joint disease
- disc prolapse
- orthostatic intolerance
- Hyperlipidaemia
- renal disease
- thyroid dysfunction
- hyperhomocysteinaemia
- hyper-/hypouremia
- hyper-/hypocalcemia
- anaemia
- hypoferremia
- Vitamin D deficiency
- deviation of blood gases from normal values (pH 7,38 - 7,42; pO2 79 - 98 mmHg; pCO2 34 - 45 mmHg; HCO3 20 - 28 mmol/l; Base excess ± 2 mmol/l)
- risk of thrombosis
- chronic back pain
- bone fracture within one year prior to study start
- bone mineral density 1,5 SD ≤ t-Score
- metal implants or other osteosynthesis material
- subject within another clinical trial within 2 months prior to study start
- any other status which according to the apprehension of the principal investigator leads to the exclusion of the subject
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01509456
Start Date
February 1 2010
End Date
October 1 2010
Last Update
March 1 2017
Active Locations (1)
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1
German Aerospace Centre (DLR)
Cologne, Germany, 51147