Oral Colecalciferol Treatment in Spinal Cord Lesion
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      Low vitamin D is frequently seen in patients with spinal cord injury (SCI) in acute and
      chronic periods. Among its causes are insufficient sun exposure, limited oral intake,
      obesity, the effect of the drugs used on the absorption of vitamin D, kidney and liver
      diseases. If we consider patients with spinal cord injuries in Turkey, it is difficult to get
      involved in the society, low exposure to the sun, lack of necessary health controls and
      immobility brings extra risk factors for the low vitamin D compared to the general
      population. Despite Turkey Endocrinology and Metabolism Endocrine Society and the
      International Endocrine Association clinical practice guidelines do not provide specific
      recommendations about vitamin D, for individuals with spinal cord injuries. Individuals with
      SCI are at high risk for low vitamin D. Vitamin D levels need to be checked and replaced.
      Vitamin D doses, application methods and dose intervals used in Physical Therapy and
      Rehabilitation clinics are different. The aim of our study is to perform the necessary
      vitamin D replacement for individuals with SCI who have vitamin D deficiency in different
      dose intervals and to compare the effects of muscle strength, muscle thickness and functional
      independence with the control group.
    

Detailed description: 
      Paraplegic patients who admitt to our Physical Therapy and Rehabilitation Clinic, will be
      included in the rehabilitation program. Sixty spinal cord injured patients with serum 25 (OH)
      D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups
      will receive 6,000 IU of vitamin D daily, and the other group 50,000 IU of vitamin D per week
      for eight weeks. Patients with high calcium (Ca) values in blood tests, patients with kidney
      stones and urinary stones in urinary ultrasonography (USG) to be performed routinely, as well
      as patients who refuse to use vitamin D supplements will include in the control group. Spinal
      cord independence measure (SCIM version 3) will be filled in at the beginning and at the end
      of 8 weeks to all participants. Jamar Dynamometer will be measured for upper extremity muscle
      strength, and biceps brachii and triceps muscle thicknesses will be measured by
      ultrasonography.
    

Intervention name(s): Vitamin D3
Intervention type(s): Drug
Intervention description(s): one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
Other intervention name(s): cholecalciferol
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Sixty patients with spinal cord injury with serum 25 (OH) D3 levels less than 20 ng / ml will be included in the study. One of the treatment groups will receive 6,000 IU of vitamin D daily, and the other group 50000 IU of vitamin D per week for 8 weeks. 20 Patients who don't receive vitamin D will be included in the control group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: 25(OH)D; hand grip strength; Spinal cord injuries; muscle thickness