Elucidating the Minimal Effective Dose of Prunes for Bone Health in Postmenopausal Women
Effect of Calcium and Vitamin D Supplements and/or Prunes on Bone Health
1 other identifier
interventional
200
1 country
1
Brief Summary
The objective of this study is to examine if calcium and vitamin D supplements and/or prune can prevent bone loss in postmenopausal women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2023
CompletedFirst Posted
Study publicly available on registry
December 28, 2023
CompletedStudy Start
First participant enrolled
March 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
July 2, 2025
May 1, 2025
4.7 years
December 14, 2023
June 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes from baseline in bone mineral density at 12 and 24 months
bone mineral density as assessed by dual energy x-ray absorptiometry
Baseline, 12 months, and 24 months
Secondary Outcomes (2)
Changes from baseline in bone specific alkaline phosphatase at 12 months and 24 months
Baseline, 12 months, and 24 months
Changes from baseline in tartrate acid phosphatase-5b at 12 months and 24 months
Baseline, 12 months, and 24 months
Study Arms (2)
Control (0 g prune/day)
NO INTERVENTIONParticipants only receive 500 mg calcium and 400 IU vitamin D daily for 24 months.
30 g prune/day
EXPERIMENTALParticipants receive 500 mg calcium and 400 IU vitamin D daily for 24 months and 30 g of prune daily for 24 months.
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal
- BMD t-score is between 0.5 and 2 SD below the mean
- Not on hormone replacement therapy (HRT) and/or other pharmacological agents known to affect bone for at least three months prior to initiation of the study
You may not qualify if:
- Women whose BMD t-score at any site falls below 2.5 SD of the mean
- Subjects receiving endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
- Subjects who smoke cigarettes or vape
- Regular consumption of dried plum or prune juice
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
San Diego State University
San Diego, California, 92182-7251, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shirin Hooshmand, PhD
San Diego State University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 14, 2023
First Posted
December 28, 2023
Study Start
March 15, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
July 2, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share