A study for the Efficacy and Safety of a Zinc and Magnesium in Improving the Prognosis of Older men with hip fracture

A Pilot, Randomized, Single-Blind, Placebo-Controlled, Multicenter Study for the Efficacy and Safety of a Nutritional Supplement Containing Zinc and Magnesium in Improving the Prognosis of Proximal Femoral Fractures in Older men - A Pilot, Multicenter RCT for the Efficacy and Safety of a Zinc and Magnesium in Improving the Prognosis of Hip Fractures in Older men

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041250192

Enrollment

Registered

2026-03-02

Start date

2026-07-14

Completion date

Unknown

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

proximal femoral fractures Femoral Neck Fractures

Interventions

Interventin group: dysphagia-specific jelly containing 12 mg of zinc and 1 mg of magnesium Control group: isotonic jelly not containg zinc and magnesium. Both groups consumed their respective jellie

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: (1) Patients newly admitted to participating facilities for postoperative rehabilitation of proximal femoral fractures (2) Males aged 60 years or older at the time of consent acquisition (3) Patients capable of consuming foods classified as Code 2 (tofu, pudding, etc.) or higher in the Japanese Dysphagia Diet 2021 by the JSDR dysphagia diet committee (JDD2021) (4) Patients for whom written consent has been obtained from the patient themselves regarding participation in this study

Exclusion criteria

Exclusion criteria: (1) Patients receiving allergen-exclusion diets due to food allergies (2) Patients receiving meals in Code 1 (paste diet) form under JDD2021 (3) Patients receiving enteral nutrition or central venous nutrition via nasogastric tube or gastrostomy due to difficulty with oral feeding (4) Patients receiving protein-restricted diets due to renal impairment (5)Patients with diabetes undergoing energy restriction and insulin administration (6) Patients with a score of 4 or lower on any cognitive item in the Functional Independence Measure (FIM) (7) Patients with psychiatric disorderst hat interfere with daily life and are deemed unable to participate in the trial (8) At the time of registration and initiation of intervention, if serum zinc is 0.13 mg/dL or higher, or serum magnesium is 2.6 mg/dL or higher (9) Patients with gastrointestinal disorders affecting absorption efficiency, such as ulcerative colitis or Crohn's disease (10) Other patients deemed ineligible for the study by the principal investigator or co-investigators

Design outcomes

Primary

Measure	Time frame
Change in serum testosterone levels	—

Secondary

Measure	Time frame
Change in free testosterone levels Bone metabolism markers	—

Contacts

Public ContactTakashi Ikeda

Nagoya City University

tk.ikeda@med.nagoya-cu.ac.jp+81-527847193

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Sep 19, 2026