Tokyo, Dec. 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060022) titled 'Effect of Vitamin D-Fortified Milk Beverage on Serum 25(OH)D Levels in Patients With Fragility Fractures: A Double-Blind Randomized Controlled Trial' on Dec. 15.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Yoshida Hospital
Condition:
Condition - Hip fracture or vertebral fracture
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate whether the intake of a vitamin D-fortified milk beverage improves serum 25(OH)D levels in patients with proximal femoral or vertebral fractures.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - 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.
Interventions/Control_2 - A milk beverage without vitamin D will be provided once daily at breakfast from admission to discharge.
Eligibility:
Age-lower limit - 65
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - 1. Patients admitted with proximal femoral fracture or vertebral fracture
2. Patients or their representatives who provide written informed consent
Key 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
Target Size - 124
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 11 Month 06 Day
Anticipated trial start date - 2025 Year 12 Month 15 Day
Last follow-up date - 2027 Year 03 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068647
Disclaimer: Curated by HT Syndication.
