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Vitamin D3 50,000 IU for Physical Fitness

Phase 2

Waitlist Available

Led By Luke J Peppone, PhD, MPH

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

Study Summary

This trial will study whether vitamin D or a placebo, with or without physical activity, can help treat bone loss in breast cancer survivors.

Eligible Conditions

Physical Fitness
Osteoporosis
Bone Biomarkers

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Measure the amount of bone loss in non-metastatic breast cancer patients receiving a high dose vitamin D therapy along with a structured home-based walking and progressive resistance exercise program.

Secondary outcome measures

Breast

Trial Design

3Treatment groups

Active Control

Group I: Vitamin D3 50,000 IUActive Control1 Intervention

Vitamin D3 50,000 IU: Patients will be assigned to receive a daily multivitamin, calcium supplement and 50,000 IU/week of vitamin D for a period of 24 weeks.

Group II: Vitamin D3 50,000 IU and Physical ActivityActive Control2 Interventions

Vitamin D3 50,000 IU and Physical Activity: Patients will be assigned to receive a daily multivitamin, calcium supplement, 50,000 IU/week of vitamin D, and a progressive walking and resistance band exercise prescription for a period of 24 weeks.

Group III: ControlActive Control1 Intervention

Patients will be assigned to receive a daily multivitamin, calcium supplement, vitamin D placebo, and standard care monitoring.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

836 Previous Clinical Trials

517,977 Total Patients Enrolled

Luke J Peppone, PhD, MPHPrincipal InvestigatorUniversity of Rochester

1 Previous Clinical Trials

108 Total Patients Enrolled

Media Library

Physical Activity Clinical Trial Eligibility Overview. Trial Name: NCT01419730 — Phase 2

Physical Fitness Research Study Groups: Vitamin D3 50,000 IU, Vitamin D3 50,000 IU and Physical Activity, Control

Physical Fitness Clinical Trial 2023: Physical Activity Highlights & Side Effects. Trial Name: NCT01419730 — Phase 2

Physical Activity 2023 Treatment Timeline for Medical Study. Trial Name: NCT01419730 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the maximum number of participants in this trial?

"This clinical trial is not presently seeking candidates. Initially posted on August 1st 2011 and most recently edited October 25th 2022, other studies are available that require physical fitness or Vitamin D3 50,000 IU supplementation. At present time there are 12 trials for the former and 33 of the latter actively recruiting patients."

Answered by AI

Has the FDA sanctioned Vitamin D3 50,000 IU as a viable therapy?

"Limited clinical evidence exists to demonstrate the safety of Vitamin D3 50,000 IU, leading our team at Power to rate it a 2 on a scale from 1-3."

Answered by AI

Has Vitamin D3 50,000 IU been tested in any prior clinical trials?

"Currently, 33 clinical trials are in progress that explore the efficacy of Vitamin D3 50,000 IU. Of these studies, 14 have reached Phase 3 and can be found at 155 different research centres with most located near Boston Massachusetts."

Answered by AI

Is this trial open to individuals aged 30 and over?

"This medical research is seeking volunteers that are 18 years or above and younger than 99."

Answered by AI

Is eligibility available for me to participate in this experiment?

"The scope of this trial encompasses 191 individuals between the ages 18-99 who meet certain physical fitness qualifications. Chiefly, they must have a treating physician's approval for submaximal testing and exercise program; be willing to quit calcium/vitamin d supplements; possess an Eastern Cooperative Oncology Group performance score ≤2 at baseline; and women should postmenopausal at time of enrollment."

Answered by AI

What health issues can be addressed through the regular consumption of Vitamin D3 50,000 IU?

"Vitamin D3 50,000 IU is commonly prescribed for calcium deficiencies and has also been used to treat fractures of the spine, post menopausal women."

Answered by AI

Are there still opportunities for individuals to participate in this experiment?

"At the moment, this research project is not accepting new participants. However, if you are seeking to join other trails there are 12 fitness studies and 33 trials for Vitamin D3 50,000 IU that are currently recruiting volunteers. This trial was first posted on August 1st 2011 and most recently updated on October 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Vitamin D and Physical Activity on Bone Health

Luke Peppone 2011. "Vitamin D and Physical Activity on Bone Health". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01419730.

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