40 Participants Needed

Nutritional Supplements for Hip Fracture

Recruiting at 1 trial location
BZ
AB
Overseen ByAshley Bandfield
Age: 65+
Sex: Any
Trial Phase: Phase < 1
Sponsor: The University of Texas Health Science Center at San Antonio
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

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.

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.12345

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.12678

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.128910

Who Is on the Research Team?

BZ

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.
See 2 more

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.
See 2 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: Nutritional SupplementsExperimental Treatment2 Interventions
Group II: ControlActive Control1 Intervention

Find a Clinic Near You

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

A systematic review of protein and energy supplementation for hip fracture aftercare in older people. [2018]
Malnutrition in hip fracture patients: an intervention study. [2022]
The effects of nutritional status on outcome after hip fracture. [2022]
For you were hungry and I gave you food: The prevalence and treatment of malnutrition in patients with acute hip fracture. [2022]
Nutritional supplementation decreases hip fracture-related complications. [2022]
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]
[Comparative study of dietary intake and nutritional status in elderly women with and without hip fracture]. [2021]
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]
Oral nutritional support in hip fracture patients. [2019]
Nutritional supplements after hip fracture: poor compliance limits effectiveness. [2019]
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