ovel versus conventional vitamin D2 supplementation protocol for correcting and retaining hypovitaminosis D after fragility hip fracture: A prospective, randomized, controlled trial

Phase 4

• Conditions: Hypovitaminosis D in fragility hip fracture patient; Vitamin D2, Hypovitaminosis D, Hip fracture, Fragility hip fracture

• Registration Number: TCTR20220725002
• Lead Sponsor: Faculty of medicine research fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-25
• Study Completion: 2024-08-01
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 170

Inclusion Criteria

1. Patients over 50 years old
2. Diagnosed with hip fracture (fracture neck of femur or fracture intertrochanter of femur) from a minor accident (simple fall from standing height or lower)

Exclusion Criteria

1. Patients who previously have received vitamin D supplements
2. patients with hypercalcemia (corrected serum calcium > 10.5 mg/dL)
3. Patients with impaired renal function (eGFR < 30 mL/min/1.73m 2 ).
4. Patients with abnormal liver function (ALT or AST > 2x of upper normal limit).
5. Other pathologic fracture confirmed by pathological reports
6. Patients receiving anticonvulsants
7. Patients with problems absorbing nutrients (short bowel syndrome, inflammatory bowel disease).
8. Patients with chronic granulomatous disease
9. Patients with multiple fractures in this visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient whose serum 25(OH)D level was greater than or equal to 30 ng/mL at 1 month after received vitamin D2 supplement protocol Percent

Secondary Outcome Measures

Name	Time	Method
Serum 25(OH)D at 1 and 3 months after supplement protocol serum level,patient whose serum 25(OH)D level was greater than or equal to 30 ng/mL at 3 months after supplemnent protocol Percentage,Serum calcium at 1 and 3 months after supplement protocol serum level,Subject with hypercalcemia 1 and 3 months after supplement protocol number,Subject with symptomatic hypercalcemia at 1 and 3 months after supplement protocol number of patient, patient reported questionaire, admission record,Serum phosphorus 1 and 3 months after supplement protocol serum level,Serum parathyroid hormone 1 and 3 months after supplement protocol serum level,Serum alkaline phosphatase 1 and 3 months after supplement protocol Serum level