Nutritional Supplements for Hip Fracture

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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

The overall objective of this pilot study is to test a comprehensive nutritional intervention in elderly patients diagnosed with hip fracture, which the study team believe will reduce functional decline, morbidity and mortality.

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.

What data supports the effectiveness of the treatment Comprehensive Nutritional Intervention for hip fracture?

Research shows that providing nutritional supplements to patients with hip fractures can significantly reduce complications and mortality rates. A study found that patients receiving a comprehensive nutritional supplement had fewer complications and lower mortality compared to those who only received regular hospital food. ^{1 2 3 4 5}

Is the nutritional supplement for hip fracture generally safe for humans?

The nutritional supplement used in the study was safe, as there were no serious adverse events reported. It also resulted in lower complication rates and mortality in patients with hip fractures compared to those who did not receive the supplement. ^{4 5 6 7 8}

How does the Comprehensive Nutritional Intervention treatment differ from other treatments for hip fracture?

Comprehensive Nutritional Intervention is unique because it focuses on improving nutritional status before and after hip fracture surgery, using a combination of oral and intravenous supplements to optimize energy and fluid intake, which can reduce complications and improve recovery outcomes. ^{3 4 5 9 10}

Research Team

Boris Zelle, MD

Principal Investigator

University of Texas Health Science Center San Antonio

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. England pubmed.ncbi.nlm.nih.gov

A systematic review of protein and energy supplementation for hip fracture aftercare in older people. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Malnutrition in hip fracture patients: an intervention study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

The effects of nutritional status on outcome after hip fracture. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

For you were hungry and I gave you food: The prevalence and treatment of malnutrition in patients with acute hip fracture. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Nutritional supplementation decreases hip fracture-related complications. [2022]

6. England pubmed.ncbi.nlm.nih.gov

What is the impact of daily oral supplementation of vitamin D3 (cholecalciferol) plus calcium on the incidence of hip fracture in older people? A systematic review and meta-analysis. [2023]

7. Spain pubmed.ncbi.nlm.nih.gov

[Comparative study of dietary intake and nutritional status in elderly women with and without hip fracture]. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Effect of calcium or 25OH vitamin D3 dietary supplementation on bone loss at the hip in men and women over the age of 60. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Oral nutritional support in hip fracture patients. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Nutritional supplements after hip fracture: poor compliance limits effectiveness. [2019]