Vitamin D Supplementation in Patients With Operated Tibia Fracture and Low Vitamin D. Does it Improve Healing Rate?. Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 682
- 试验地点
- 2
- 主要终点
- Fracture non union
研究概览
简要总结
This study evaluates the effect of Vitamin D3 supplementation in healing rate of tibia fractures in adult patients with low vitamin D. Half of participants will receive Vitamin D3 supplementation while the other will receive placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Tibial fracture
- •ASA physical status classification system I-II.
- •25 hydroxyvitamin D below 30ng/ml)
- •Fracture treatment with reamed intramedullary nail
排除标准
- •Open Fractures Gustillo III B and III C
- •Closed Soft tissue injury with Tscherne classification of III
- •Acute Compartment Syndrome
- •Pathology fractures (That occur in abnormal bone, for example in the presence of tumor, cyst or Paget disease)
- •Other Fractures in lower limbs or spine that does not allow full weight bearing of the operated tibia after 4 weeks
- •More than 7 days of evolution from fracture occurrence
- •Diabetes mellitus with HbA1c more or equal than 7%
- •Peripheral vascular disease
- •Pre-existing disorders of the metabolism of Vitamin D and/or homeostasis of calcium and phosphorous (ie. Hepatic insufficiency, congenital defects of the vitamin D metabolism, disorders of the parathyroid glands, hypo or hyper calcemia)
- •Renal failure with glomerular filtration rate below 60ml/min according to MDRD-
- •Patients using nephrotoxic medications in high doses, requiring periodical monitoring of glomerular filtration rate
- •Patients undergoing with nephrotic syndrome or that suffered it in the past
- •Patients that suffered nephrolithiasis or urolithiasis
- •Pregnant women
- •Patients with allergy to vitamin D or other contraindications for vitamin D3 prescription
- •Patients that are taking multivitamin supplements containing vitamin D and will not suspend taking them during the study.
- •Patients that are not able to swallow a cup of water
研究组 & 干预措施
Vitamin D3 supplementation. Deficiency.
Vitamin D3 50.000 UI in each packet of powder for solution. Two packets every week for 5 weeks.
干预措施: Vitamin D3. (Dietary Supplement)
Placebo. Deficiency.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 5 weeks.
干预措施: Placebo (Dietary Supplement)
Vitamin D3 supplementation.Insufficiency
Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
干预措施: Vitamin D3. (Dietary Supplement)
Placebo. Insufficiency.
Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution. Two packets every week for 3 weeks.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Fracture non union
时间窗: 2 years
Rate of fracture non union in each group
次要结局
- Short Form 36 score (SF-36)(2 years)
- Deep infections(2 years)
- EuroQol five dimensions questionnaire (EQ-5D)(2 years)
- Knee Range of movement(2 years)
- Ankle Range of movement(2 years)
- Superficial Infections(2 years)
- Visual Analogue Scale (VAS)(2 years)
- Prevalence of low vitamin D in adults with tibia fracture(10 days)
- Time of fracture healing(2 years)
研究者
Sebastián Drago Pérez
Orthopedic Surgeon
Hospital del Trabajador de Santiago