Nutritional Supplements for Hip Fracture

No longer recruiting at 1 trial location

Overseen By Ashley Bandfield

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Open fractures, Decisional impairment, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether certain nutritional supplements can aid elderly patients in recovering better after a hip fracture. The goal is to determine if these supplements can reduce complications and enhance recovery post-surgery. Participants will either receive a comprehensive nutritional intervention (a specific set of nutritional supplements) or follow standard care procedures. Suitable candidates have had a hip fracture, plan to undergo surgery to repair it, and can take oral medications. As an Early Phase 1 trial, this research seeks to understand how these supplements function in people, offering participants an opportunity to contribute to groundbreaking discoveries in recovery care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that multivitamins like Centrum Silver 50+ may help protect against hip fractures, offering reassurance to those concerned about osteoporosis, a condition where bones become weak and brittle. However, Centrum Silver is not recommended for children under 12 due to the risk of excessive vitamin intake.

Another supplement, Juven, is often used for recovery and healing. Although specific safety data for Juven in this context is lacking, it is generally used without major problems.

Overall, adults usually tolerate nutritional supplements like these well. However, caution is advised with high doses of B vitamins, as large amounts have been linked to more hip fractures in older women.

For those considering joining a trial like this, it is important to know that the study is in its earliest stage, focusing mainly on the safety and tolerability of these supplements. Always consult a doctor to determine what is best. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the use of nutritional supplements like Juven and Centrum Silver 50+ for treating hip fractures because they offer a unique approach compared to traditional methods. Unlike standard care that often focuses on surgery, pain management, and physical therapy, these supplements aim to enhance recovery by providing essential nutrients that may promote bone healing and overall health. Juven, for instance, contains a mix of amino acids like arginine and glutamine, which could support tissue repair and immune function. Centrum Silver 50+ is tailored for older adults and includes vitamins and minerals that are crucial for maintaining bone density. This nutritional intervention could potentially speed up recovery and improve outcomes for patients with hip fractures.

What evidence suggests that this comprehensive nutritional intervention might be an effective treatment for hip fracture?

Research has shown that nutrition can aid recovery after a hip fracture. In this trial, one group will receive nutritional supplements, specifically Juven and Centrum Silver 50+, to assess their impact on recovery. One study found that oral nutritional supplements improved recovery in older patients after hip surgery. Another study found that a focused nutrition plan helped elderly patients eat better and improve their health after a hip fracture. These findings suggest that a well-rounded nutrition plan could reduce complications and speed up recovery. While more research is needed, early results are promising for using nutritional supplements to support healing and lower health risks in this group. ^{6 7 8 9 10}

Who Is on the Research Team?

Boris Zelle, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Are You a Good Fit for This Trial?

This trial is for men and women aged 65-89 who have a closed hip fracture needing surgery. They must be able to take pills, follow the study's drug schedule, and adhere to nutritional advice. It's not for those with open fractures, prisoners, certain surgical cases outside fixation or arthroplasty, allergies to the study drugs, or those who can't tolerate oral supplements.

Inclusion Criteria

Provision of signed and dated informed consent form

My doctor says I need surgery for my bone or joint issue.

I have a broken hip bone in the upper part near the joint.

Exclusion Criteria

I have a broken bone that is exposed through my skin.

I have had surgery on my hip that wasn't just a repair or joint replacement.

I have difficulty making decisions due to a mental condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nutritional supplements (Juven and Centrum Silver 50+) or standard care post hip fracture surgery

26 weeks

Follow-up

Participants are monitored for secondary fractures, hospital readmissions, surgical complications, quality of life, and grip strength

26 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Comprehensive Nutritional Intervention

Trial Overview The trial is testing a comprehensive nutrition plan using Juven and Centrum Silver 50+ in elderly patients with hip fractures. The goal is to see if this approach reduces their functional decline as well as morbidity (health complications) and mortality after surgery.

How Is the Trial Designed?

Group I: Nutritional Supplements Experimental Treatment 2 Interventions

Juven and Centrum Silver 50+ will be administered to this group

Group II: Control Active Control 1 Intervention

Standard of care procedures

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05971173

NCT05971173 | Nutritional Optimization and Bone Health ... The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study ...

2. academic.oup.com academic.oup.com/jbmr/advance-article-pdf/doi/10.1093/jbmr/zjaf030/61940792/zjaf030.pdf

UNCORRECTED MANUSCRIPT - Oxford Academic The primary outcomes for the present study were total clinical fracture, hip fracture, and non-vertebral fracture, as in our prior study evaluating fracture ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05971173/nutritional-optimization-and-bone-health-management-for-older-adults-undergoing-hip-fracture-surgery?id=111&slug=osteoporosis

Nutritional Optimization and Bone Health Management for ... The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37907073/

Effect of oral nutritional supplementation on outcomes in ... This meta-analysis aims to determine whether oral nutritional supplementation (ONS) improves postoperative outcomes in older patients with a hip ...

5. researchgate.net researchgate.net/publication/323917437_Efficacy_of_Nutritional_Intervention_in_Elderly_After_Hip_Fracture_A_Multicenter_Randomized_Controlled_Trial

(PDF) Efficacy of Nutritional Intervention in Elderly After Hip ... Conclusions: Intensive nutritional intervention after hip fracture improved nutritional intake and status, but not LOS or clinical outcomes.

6. nytimes.com nytimes.com/2019/05/28/well/live/high-doses-of-b-vitamins-tied-to-hip-fractures-in-women.html

High Doses of B Vitamins Tied to Hip Fractures in Women Large doses of vitamin B supplements are linked to an increased risk for hip fracture in older women, researchers report.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33575883/

Multivitamins and risk of fragility hip fracture: a systematic ... Our meta-analysis indicates that multivitamin use is significantly protective against osteoporotic hip fracture.

8. webmd.com webmd.com/drugs/2/drug-9881-540/centrum-silver-oral/multivitamin-folic-acid-selected-minerals-oral/details

Centrum Silver - Uses, Side Effects, and More This medication is not recommended for use in children under 12 because of increased risk of some vitamins/minerals building up to harmful levels in the body.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6464805/

Nutritional supplementation for hip fracture aftercare in older ... Older people with hip fractures are often malnourished at the time of fracture, and subsequently have poor food intake. This is an update of a Cochrane ...

10. academic.oup.com academic.oup.com/jbmr/article-pdf/40/5/591/61940792/zjaf030.pdf

Effects of cocoa extract supplementation and multivitamin ... Compared with placebo, cocoa extract was not significantly associated with lower risk of incident clinical fracture (adjusted hazard ratio [aHR] ...