NCT04183075

Brief Summary

Multicenter, prospective, randomized, double-blind, interventional study with a nutritional supplement against placebo in a cohort of patients hospitalized for hip fracture.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
9 months until next milestone

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

8 months

First QC Date

November 25, 2019

Last Update Submit

September 17, 2020

Conditions

Hip FracturesMalnutrition

Keywords

phase anglenutritional supplement

Outcome Measures

Primary Outcomes (2)

  • Compare changes in nutritional status between groups based on phase angle

    Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on phase angle measurement (morphological criterion)

    From baseline to month 4

  • Compare changes in nutritional status between groups based on force measurement

    Compare changes in nutritional status between patients taking nutritional supplement under study and control group based on force measurement using hand-grip strength ( functional criteria).

    From baseline to month 4

Secondary Outcomes (8)

  • To compare functional recovery

    From baseline to month 4

  • To compare the morphological recovery by muscle ultrasound

    From baseline to month 4

  • To compare changes in Mini Nutrition Assessment test for aged people

    From baseline to month 4

  • To compare the evolution of the Global Subjective Valuation questionnaire

    From baseline to month 4

  • Compare changes between groups in the Charlson index

    From baseline to month 4

  • +3 more secondary outcomes

Study Arms (2)

FontActiv Superprotein/Hypercaloric Fiber

EXPERIMENTAL

Full Nutritional Supplement

Dietary Supplement: FontActiv Superprotein/Hypercaloric Fiber

Carbohydrates and C Vitamin

ACTIVE COMPARATOR

Nutritional Supplement

Dietary Supplement: Carbohydrates and C Vitamin

Interventions

FontActiv Superprotein/Hypercaloric FiberDIETARY_SUPPLEMENT

The product under study has a liquid presentation, in 200 ml bottles, ready to take

FontActiv Superprotein/Hypercaloric Fiber
Carbohydrates and C VitaminDIETARY_SUPPLEMENT

The control product will be prepared with equal presentation and taste as similar as possible tan study product

Carbohydrates and C Vitamin

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Patients over 65 years old.
  • Patients admitted to hospital by spontaneous hip fracture and requiring surgery.
  • Patients who after hip intervention are included in rehabilitation protocols with outpatient rehabilitation plan.
  • Patients who agree to participate by signing informed consent or their regular caregivers grant consent.

You may not qualify if:

  • Patients who have a hip fracture from high-impact trauma or secondary to bone pathology (such as neoplasm).
  • Patients with concomitant diseases such as severe hepatic impairment, severe renal impairment, insulin-dependent diabetes melitus and decompensated diabetes mellitus.
  • Patients who require clinical stabilization before surgery beyond 72 hours.
  • Patients receiving emergency surgery.
  • Patients with previous prostheses.
  • Patients with pacemakers.
  • Patients who are not likely to complete the follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital Clínico de Málaga

Málaga, Andalusia, 29010, Spain

Location

Hospital Virgen del Rocío

Seville, Andalusia, 41013, Spain

Location

MeSH Terms

Conditions

Hip FracturesMalnutrition

Interventions

CarbohydratesAscorbic Acid

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg InjuriesNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy Acids

Study Officials

  • Jose Manuel Garcia Almeida

    Hospital Clínico de Málaga

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser De Castellar, MD

CONTACT

+34 902105243RDeCastellar@ordesa.es

Sandra Vidal, PhD

CONTACT

+34 935 516 072svidal@grandfontaine.eu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 3, 2019

Study Start

September 1, 2020

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

ES(2)