Nutritional Support in Femur Fracture Rehabilitation

NCT04306536 | Terminated

• 1 other identifier: parere 72_2020bis
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, observer-blinded trial tested the hypothesis that nutritional supplementation with muscle-target nutritional supplementation would increase the efficacy of a physical rehabilitation program in old adults with femur fracture treated with surgery.

Conditions

Femur Fracture

Outcome Measures

Primary Outcomes (1)

• Physical performance - gait speed

  Gait speed at the 10-meter walking test

  4 weeks

Secondary Outcomes (10)

• Physical performance - Timed Up and Go test

  4 weeks

• Functional status - Barthel

  4 weeks

• Functional status - handgrip strength

  4 weeks

• Body composition - phase angle

  4 weeks

• Body composition - muscle mass

  4 weeks

Study Arms (2)

Fortifit®

EXPERIMENTAL

Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.

Dietary Supplement: Fortifit®

Control group

NO INTERVENTION

Best local diet

Interventions

Fortifit® DIETARY_SUPPLEMENT

Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.

Fortifit®

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 60 years or older
• admission for physical rehabilitation after surgery for femur fracture
• informed consent

You may not qualify if:

• Any malignant disease during the last five years
• Known kidney failure (previous glomerular filtration rate \<30 ml/min);
• Known liver failure (Child B or C)
• Psychiatric disease
• Severe cognitive impairment (Mini Mental State Examination \<18)
• Endocrine disorders associated with disorders of calcium metabolism (excluding osteoporosis)
• Indications related to the study product:
• More than 10 µg (400 IU) of daily Vitamin D intake from medical sources
• More than 500 mg of daily calcium intake from medical sources.
• Adherence to a high-energy or high-protein diet (up to three months before starting the study)
• Hypersensitivity to any component of the investigational nutritional supplement (including cow milk protein allergy to milk and lactose intolerance)
• Indication to or ongoing artificial nutrition support
• Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
• Refusal

Sponsors & Collaborators

• Barichella Michela: lead

Study Sites (1)

Asst Gaetano Pini

Milan, Italy

Location

MeSH Terms

Conditions

Femoral Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Lorenzo Panella, MD

  ASST Gaetano Pini-CTO

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study coordinator

Study Record Dates

• First Submitted: March 10, 2020
• First Posted: March 13, 2020
• Study Start: June 19, 2020
• Primary Completion: December 20, 2020
• Study Completion: December 20, 2020
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

IT (1)