The Effect of Vitamin D on the Consolidation of Extra-articular Fractures - a double-blind randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20608

Enrollment

250

Registered

2014-01-26

Start date

2014-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Vitamin D

Interventions

Group studie medication: 25.000IU Colecalciferol once a month during a period of 4 months. Group placebo: Placebo once a month during a period of 4 months.

Eligibility

Inclusion criteria

Inclusion criteria: - Age between 18 and 50 years - Extra-articular fracture of a long bone (clavicle, humerus, radius, antebrachii, femur, tibia, cruris or Weber A, B or C fracture)

Exclusion criteria

Exclusion criteria: - Refracture; pathologic fracture; complicated fracture; Injury severity Score > 16; pregnancy - Growth hormone deficiency; Immune compromised, sarcoïdosis - Use of: Vitamin D, corticosteroids, digoxin, calcium / bisfosfonate, phenobarbital, phenytoïn

Design outcomes

Primary

Measure	Time frame
Delayed union, defined as incomplete consolidation (clinically and radiologically) after 4 months.	—

Secondary

Measure	Time frame
- Non-union, defined as absent fracture consolidation after 9 months - Complications during fracture healing (infection, mal-Union, refracture, (re)operation). - Perceived pain - Functional recovery - Quality of life - Cost(effectiveness)	—

Contacts

Public ContactI.B. Schipper

PO-box 9600

i.b.schipper@lumc.nl+31 (0)71 5264005

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)