A randomized controlled trial study comparing high- and low-dose vitamin D2 supplementation protocol in patients with osteoporotic hip fractures
- Conditions
- Proportion of low energy hip fracture patients who had normal serum vitamin D level after three months of treatment in different dose of vitamin D2 supplement.
- Registration Number
- TCTR20180302007
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 159
All patient who admitted to Siriraj Hospital , Mahidol University, Bangkok, Thailand, between July,10 2016 †June, 15 2017. They were invited to participate if they were aged 50 years or over and presenting with a low energy hip fracture, peritrochanteric or neck of femur fracture
patients who suffered from associated pathological fracture from malignancy or other metabolic bone disease such as paget’s disease, Hyperparathroidism; hypercalcemia (>10.2 mg/dL)[27];
history of disease that high risk for altered serum calcium level such as tumor, granulomatous disease;
significant renal impairment (GFR ≤ 30 ml/min);
liver disease (AST or ALT level >2 times the upper limit of the normal range); undergoing supplement with oral vitamin more than 400 IU daily; undergoing treatment with drug that may altered serum 25(OH)D level such as phenytoin, phenobarbital;
history of malabsorbtion disease such as radiation enteritis, inflammatory bowel disease, short bowel syndrome.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of low energy hip fracture patients who had normal vitamin D level 12 weeks serum 25(OH)D >=30 ng/mL,Proportion of low energy hip fracture patients who had normal vitamin D level 12 weeks serum 25(OH)D >=30 ng/m
- Secondary Outcome Measures
Name Time Method Serum calcium level of low energy hip fracture patients 12 weeks Change in serum calcium level, ng/m