Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury

NCT04217577 | Terminated

• 1 other identifier: KIB0033
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• Change in Procollagen Type I Intact N-Terminal Propeptide (P1NP)

  Blood marker of bone formation

  change from baseline to 12 months

• Change in C-terminal telopeptide (CTX)

  Blood marker of bone resorption

  change from baseline to 12 months

• Change in Bone mineral density (BMD) - multiple sites

  BMD of hip and knee

  change from baseline to 12 months

Study Arms (1)

Dried Plums

EXPERIMENTAL

Consume dried plums daily.

Dietary Supplement: Dried plums

Interventions

Dried plums DIETARY_SUPPLEMENT

10-16 dried plums/day, approximately 100-120 g/day

Dried Plums

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• chronic injury greater than 4 yr and
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Palo Alto Health Care System: lead

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Health Scientist

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 3, 2020
• Study Start: January 20, 2019
• Primary Completion: March 20, 2020
• Study Completion: March 20, 2020
• Last Updated: October 25, 2021

Record last verified: 2021-10

Locations

US (1)