Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury
Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury
The purpose of this pilot study is to explore whether dried plum (prunes) added to the diet
 is effective in reducing or reversing bone loss following spinal cord injury (SCI). The
 investigators will look for changes in bone mineral density as well as evidence in the blood
 of markers of bone activity. The first part of the study is to check whether participants
 with SCI can and will eat the required amount of dried plums (prunes) on a daily basis. The
 second part of the study is to follow participants over one year and look for changes in bone
 mass and blood markers.
Recruitment & screening: SCI clinicians will invite patients from the VA SCI Center census to
 participate in the pilot in person during a clinic visit or inpatient admission. If the
 patient is interested, one of the study team will explain the study and obtain consent. The
 study will be performed on an outpatient basis with return to the VA for study visits at 3, 6
 ,9 , and 12 months.

 The investigators will mail Opt-Out Letters to individuals who have been identified as
 potentially eligible. The Opt-Out Letter will include a Response Letter and a Return
 Self-addressed Stamped Envelope (attached). If the investigators do not receive a NO response
 by phone or mail after 2 weeks, they will attempt to call using an Opt-Out Telephone Script
 and Recruitment Script (Attached).

 Screening is primarily done based on interest, medical history and contraindications. There
 may be blood values, collected at baseline that indicate ineligibility, but these will be
 determined on individual cases. Interest in the study and commitment to maintain the study
 diet/intake will be important to ascertain - although the investigators anticipate that there
 may be dropout or reduced compliance with time.

 Procedures:

 1. For the first month, each participant will consume 6-8 prunes per day to determine
 tolerability. Starting in Month 2, each participant will consume approximately 10-16
 prunes/day (<120 g), depending on the size of the prune. The smaller prunes weigh about
 7 g and the larger weigh up to 10 g. It will be suggested to consume 5-8 prunes twice
 per day for breakfast and dinner. However, this is not a requirement, so long as the
 per-day goal is met. If a participant does not eat the daily requirement one day they
 will be encouraged to make up the difference over the next 6 days such that the total is
 equal to the required 100-112 total prunes for the week. If however, they miss multiple
 days of prune consumption, they will be asked to contact the study coordinators to
 develop a reasonable plan to get back on track.

 2. Participants will be asked to track consumption regularly by use of a chart. They will
 be instructed to note days when they missed or consumed fewer prunes. They will also be
 instructed to note any changes in bowel or other function and contact study staff with
 any questions.

 Assessments:

 1. Bone mineral density by dual xray absorptiometry (DXA) to include the following sites:
 total body, spine, bilateral hip, bilateral knee. Total body scans will be obtained at
 baseline and at 12 months; all other scans will be obtained at baseline, 3, 6, 9, and 12
 months.

 2. Blood assessments will be collected at the same intervals and will include serum
 concentrations of C-terminal telopeptide (CTX), which is a bone resorption marker, and
 Procollagen Type I Intact N-Terminal Propeptide (P1NP), a bone formation marker to
 measure the rate and direction of bone metabolism during the study. Serum will be frozen
 for batch processing. Safety labs will also be drawn including a comprehensive metabolic
 panel, primarily to monitor renal function, calcium concentration, and blood sugar.
 Magnesium and phosphorus levels will also be analyzed. De-identified, coded blood
 samples will be sent to Quest Diagnostics Lab (contracting lab) for analysis.

 3. Surveys will be administered to the participants at 0, 3, 6, 9, and 12 months. These
 will include the Global Health Scale- to evaluate overall health and well-being, the
 Spinal Cord Injury Quality of Life Questionnaire (SCI-QOL) on Bowel Management as well
 as the Bristol Stool Chart-to ascertain any affects the consumption of prunes have on
 participants' bowel habits. Finally participants will be given a brief questionnaire
 regarding their activity level, general health status, lifestyle habits, and
 participation characteristics while in the study.

 Study Contact: For the first month, study staff will call each participant weekly to ask
 about any concerns or issues related to prune consumption. After this, calls will be less
 frequent, biweekly for the next month(s) and once per month after this. As this is a pilot
 study, the investigators may adjust the call frequency as needed to determine if more or
 fewer calls are needed. One of the main goals of this pilot is to determine feasibility
 related to regular consumption; the investigators feel that useful information can be
 gathered by calling rather than waiting for the participant to contact us.
Inclusion Criteria:

 -  SCI at any level, America Spinal injury Association (ASIA) Impairment Scale = A-C

 -  Primarily wheelchair-user

 -  Age - between 18 and 65 years old.

 -  Two cohorts will be recruited:

 1. chronic injury greater than 4 yr and

 2. newly injured, less than 4 years

 -  The investigators will target Vit D blood level to be 20 ng/ml or higher and suggest
 that any potential participants with Vit D greater than 10 but below 20 receive a
 clinical protocol to achieve 20 ng/ml.

 Exclusion Criteria:

 -  Presence of hyper/hypo-parathyroidism, renal insufficiency (GFR<60ml/min), currently
 taking hormone replacement therapy, severe vitamin D deficiency (<10 ng/ml), thyroid
 disease, active cancer diagnosis, currently using bisphosphonate or parathyroid
 hormone therapy, diagnosed fracture less than 3 months ago, current pressure sore
 stage III or IV, New York Heart Association (NYHA) functional classification of stage
 II-IV, inflammatory bowel disease, cirrhosis of the liver, consuming more than 3 dried
 plums/day as their regular diet.

 -  Vitamin D blood level below 10 ng/ml