Skip to content

Effect of Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures: A Double-Blind Randomized Controlled Trial

A Double-Blind Randomized Controlled Trial to Evaluate the Effect of a Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures - VD-FF Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060022
Enrollment
124
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hip fracture or vertebral fracture

Interventions

A vitamin D-fortified milk beverage containing 9.0 micrograms of vitamin D per bottle will be provided once daily at breakfast from admission to discharge. A milk beverage without vitamin D will be

Sponsors

Yoshida Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients admitted with proximal femoral fracture or vertebral fracture 2. Patients or their representatives who provide written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to dairy products (such as allergy or intolerance) 2. Patients with severe swallowing disorders that make oral intake of the milk beverages difficult 3. Patients judged by the attending physician to be medically unsuitable for participation

Design outcomes

Primary

MeasureTime frame
Change in serum 25(OH)D levels from admission to discharge.

Secondary

MeasureTime frame
1. Improvement rate of vitamin D deficiency (proportion of patients with serum 25(OH)D >= 20 ng/mL at discharge) 2. Serum 25(OH)D level at discharge 3. Changes in Functional Independence Measure (FIM) scores 4. Change in Skeletal Muscle Mass Index (SMI) 5. Incidence of adverse events, defined as decreased renal function (eGFR < 60 mL/min/1.73m2) or hypercalcemia (serum calcium >= 10.5 mg/dL)

Countries

Japan

Contacts

Public ContactAraki Saito

Yoshida Hospital Department of Nutrition

araki.saito0527@gmail.com0258-32-0490

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026