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NOT YET RECRUITING
NCT07780006
NA

Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty

Sponsor: Thammasat University

View on ClinicalTrials.gov

Summary

This study aim to compare the efficacy of oral nutritional supplementation (ONS) in femoral neck fracture patients undergoing hip arthroplasty compared with placebo. The hypothesis is "Oral nutritional supplement with Beta-hydroxy-beta-methylbutyrate (HMB) can improve muscle strength in femoral neck fracture patients undergoing hip arthroplasty". Femoral neck fracture patients aged more than 65 years will be enrolled and allocated into 2 groups * ONS group: Oral nutritional supplement (Ensure® Plus Advance) 2 serves / day x 30 days + Standard oral intake * Control group: Standard oral intake Primary outcome is Grip strength, assessed using hand dynamometer on admission and 2, 6, 12 weeks postoperatively. Secondary outcomes are * Serum albumin assessed on admission and 2, 6, 12 weeks postoperatively * Barthel index assessed at 2, 6, 12 weeks postoperatively * Mini Nutritional Assessment (MNA), Geriatric Nutritional Risk Index (GNRI) assessed at 2, 6, 12 weeks postoperatively * Length of stay (day) * Time up and go (TUG), assessed at 2, 6, 12 weeks postoperatively * Oxford hip score (OHS), assessed at 2, 6, 12 weeks postoperatively * Complications, rate of readmission, mortality rate assessed until 3 months

Official title: Efficacy of Oral Nutritional Supplement in Femoral Neck Fracture Patients Undergoing Hip Arthroplasty: A Randomized Controlled Trial

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10

Completion Date

2027-12

Last Updated

2026-08-21

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Oral nutritional supplementation

Oral nutritional supplement that consists of 20 grams of protein, 1.5 grams of calcium β-hydroxy-β-methylbutyrate (CaHMB), 0.5 gram of calcium, 500 international units (IU) of vitamin D and calories of 330 kcal per one bottle of 220 ml (Ensure® Advance Plus, Abbott Laboratorios S.A.)

Locations (1)

Thammasat University

Pathum Thani, Thailand