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临床试验/NCT04217577
NCT04217577终止不适用

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

VA Palo Alto Health Care System2 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2019年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
4
试验地点
2
主要终点
Change in Bone mineral density (BMD) - multiple sites

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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

结局指标

主要结局

Change in Bone mineral density (BMD) - multiple sites

时间窗: change from baseline to 12 months

BMD of hip and knee

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

时间窗: change from baseline to 12 months

Blood marker of bone formation

Change in C-terminal telopeptide (CTX)

时间窗: change from baseline to 12 months

Blood marker of bone resorption

次要结局

未报告次要终点

研究者

发起方
VA Palo Alto Health Care System
申办方类型
Fed
责任方
Principal Investigator
主要研究者

Beatrice Jenny Kiratli PhD

Research Health Scientist

VA Palo Alto Health Care System

研究点 (2)

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