1. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation PI: Peggy A. Whitson, Ph.D. CoIs:Charles Y.C. Pak, M.D. Jeffrey A. Jones, M.D. Clarence F. Sams, Ph.D. Robert A. Pietrzyk, M.S.

2. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Training Session Agenda: Brief Science Review Experiment Activities BDC In-flight Postflight Procedures Potassium Citrate/Placebo Bar Code Reader Urine Collection Adapter Options

3. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Why Renal Stones ? 5% of the U.S. population is afflicted with renal stones. 75% recurrence rate if untreated. 1,000,000 hospitalizations per year. Peak stone-forming years are between the ages of 35 - 50. Fourteen renal stone occurrences in U.S. crewmembers, one in- flight episode in Russian cosmonaut indicates the high risk to crewmembers health. Calcium oxalate, calcium phosphate, and uric acid comprise the major types of renal stones.

4. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation ISS Mission Objectives: Continue to assess the effect of space flight on the risk for renal stone formation. Evaluate the influence of dietary intake on the urinary biochemistry. Assess the influence of microgravity on urinary protein inhibitor levels. Evaluate the ability of potassium citrate to minimize the risk renal stone development.

5. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Training Objectives: Recognize and competently use the flight hardware. Collect and process a simulated urine sample. Scan IMS labels for experiment specific items. Enter information for diet/food/fluid into logbook. Review experiment timeline for pre-, in- and postflight activities. Discuss selection of urine collection adapter.

6. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Experiment Design L-195 to L-190 L-61 to L-60 L-11 to L-10* >FD3 - < FD14 >FD45 - < FD80 Within 30 days of undocking R+0* to R+2 R+6 to R+7 R+13 to R+14 * L-10 and R+0 BDC sessions may be combined with MedOps requirements. 24-hour urine collection 48-hour dietary logging Potassium citrate or placebo ingestion on all FDs 24-hour urine collection 48-hour dietary logging Potassium citrate or placebo ingestion from R+0 to R+14 24-hour urine collection 48-hour dietary logging Potassium citrate or placebo ingestion from L-3 to launch Preflight (days)In-flight (days)Postflight (days)

7. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation FDA approved for treatment in renal stone disease Extensive testing in clinical trials Widely used by renal stone sufferers for many years Almost complete no recurrence rate in stone-formers Why potassium citrate ?

8. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Experiment Success Accurate and complete recording of diet and fluid intake Complete 24–hour void-by-void urine collection Proper identification of in-flight samples Daily ingestion of Potassium Citrate or Placebo tablets

9. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Experiment Benefits Opportunity to assess in-flight and postflight changes in urine chemistry that may lead to renal stone formation. Evaluation of countermeasures to minimize the renal stone risk, especially during extended duration missions. Avoidance of a medical contingency evacuation resulting from in-flight kidney stone formation.

10. ISS: Nom Ops P.I. P.A. Whitson, Ph.D. Johnson Space Center, Houston, Texas E057: Renal Stone Risk During Space Flight: Assessment and Countermeasure Validation Effect of Potassium Citrate on Bone Density 3 independent studies have shown increased bone density in renal stone patients on potassium citrate therapy. Objective: Using the data from the renal stone countermeasure study, evaluate the effects of citrate on bone ISS crewmember participation: request from investigators to obtain pre- and postflight bone density data and pre, in- and postflight additional urinary bone marker analysis. All data coded to ensure crewmember privacy. Requirements: Additional informed consent No added crew time No added sample requirements Benefits: Increased bone density or reduce risk of bone loss Potential for less in-flight exercise Minimize risk of stone formation