Clinical trial NCT04400747: Oral Colecalciferol Treatment in Spinal Cord Lesion
Official title: The Effects of Single High-dose or Daily Low Dosage Oral Colecalciferol Treatment on Muscle Strength, Muscle Thickness and Independence in Spinal Cord Lesion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injury
Keywords: 25(OH)D
hand grip strength
Spinal cord injuries
muscle thickness
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. 18-60 years old
2. Thoracic level chronic spinal cord injury
3. A, B, C, D complete / incomplete patients according to ASIA classification
4. 25 (OH) D3 level in serum is \<20 ng / ml
5. Complete muscle strength in upper extremity

Exclusion Criteria:

1. Individuals with chronic liver, kidney, respiratory and parathyroid disease
2. Chronic constipation
3. Patients who have recently used vitamin D
4. Use of drugs that will affect vitamin D and Ca level (Thiazide group diuretics, statins)
5. Acute inflammation (may show false low in vitamin D levels)

Primary outcomes:
measure: Hand grip strength
timeFrame: 8 weeks
Secondary outcomes:
measure: Spinal cord İndependence Measurement (SCIM version 3)
timeFrame: 8 weeks
measure: Muscle thickness
timeFrame: 8 weeks
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training & Research Hospital
name: Demet Ferahman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hummel K, Craven BC, Giangregorio L. Serum 25(OH)D, PTH and correlates of suboptimal 25(OH)D levels in persons with chronic spinal cord injury. Spinal Cord. 2012 Nov;50(11):812-6. doi: 10.1038/sc.2012.67. Epub 2012 Jun 19.
citation: Bauman WA, Zhong YG, Schwartz E. Vitamin D deficiency in veterans with chronic spinal cord injury. Metabolism. 1995 Dec;44(12):1612-6. doi: 10.1016/0026-0495(95)90083-7.
citation: Lamarche J, Mailhot G. Vitamin D and spinal cord injury: should we care? Spinal Cord. 2016 Dec;54(12):1060-1075. doi: 10.1038/sc.2016.131. Epub 2016 Sep 20.
citation: Holick MF, Binkley NC, Bischoff-Ferrari HA, Gordon CM, Hanley DA, Heaney RP, Murad MH, Weaver CM; Endocrine Society. Evaluation, treatment, and prevention of vitamin D deficiency: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Jul;96(7):1911-30. doi: 10.1210/jc.2011-0385. Epub 2011 Jun 6.
citation: Bauman WA, Morrison NG, Spungen AM. Vitamin D replacement therapy in persons with spinal cord injury. J Spinal Cord Med. 2005;28(3):203-7. doi: 10.1080/10790268.2005.11753813.