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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217577
Recruitment Status : Enrolling by invitation
First Posted : January 3, 2020
Last Update Posted : January 6, 2020
Sponsor:
Information provided by (Responsible Party):
Beatrice Jenny Kiratli PhD, VA Palo Alto Health Care System

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Dietary Supplement: Dried plums Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dried Plum Supplementation as Treatment for Bone Loss Following Spinal Cord Injury
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dried Plums
Consume dried plums daily.
Dietary Supplement: Dried plums
10-16 dried plums/day, approximately 100-120 g/day




Primary Outcome Measures :
  1. Change in Procollagen Type I Intact N-Terminal Propeptide (P1NP) [ Time Frame: change from baseline to 12 months ]
    Blood marker of bone formation

  2. Change in C-terminal telopeptide (CTX) [ Time Frame: change from baseline to 12 months ]
    Blood marker of bone resorption

  3. Change in Bone mineral density (BMD) - multiple sites [ Time Frame: change from baseline to 12 months ]
    BMD of hip and knee



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217577


Locations
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United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304
Sponsors and Collaborators
VA Palo Alto Health Care System
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Responsible Party: Beatrice Jenny Kiratli PhD, Research Health Scientist, VA Palo Alto Health Care System
ClinicalTrials.gov Identifier: NCT04217577    
Other Study ID Numbers: KIB0033
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 6, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: This is very preliminary and we are not sure yet if sharing will be valuable as we may make protocol amendments depending on study data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System