Oral Colecalciferol Treatment in Spinal Cord Lesion

Spinal Cord Injury Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04400747
• Other study ID #: PMRIST
• Status: Completed
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: January 4, 2021

Study information

• Verified date: February 2021
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 4, 2021
• Est. primary completion date: January 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Intervention

Drug:
• Vitamin D3
one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training & Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

Bauman WA, Zhong YG, Schwartz E. Vitamin D deficiency in veterans with chronic spinal cord injury. Metabolism. 1995 Dec;44(12):1612-6. — View 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. Erratum in: J Clin Endocrinol Metab. 2011 Dec;96(12):3908. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hand grip strength	Measurement of both hands grip strength by Jamar dynamometer	8 weeks
Secondary	Spinal cord Independence Measurement (SCIM version 3)	The SCIM has been developed to address three specific areas of function in patients with spinal cord injuries (SCI). It looks at self-care (feeding, grooming, bathing, and dressing), respiration and sphincter management, and a patient's mobility abilities (bed and transfers and indoors/outdoors).	8 weeks
Secondary	Muscle thickness	Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.	8 weeks