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Oral Colecalciferol Treatment in Spinal Cord Lesion

Primary Purpose

Spinal Cord Injury

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Vitamin D3
Sponsored by
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring 25(OH)D, hand grip strength, Spinal cord injuries, muscle thickness

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

weekly treatment group

daily treatment group

control group

Arm Description

Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 50,000 IU of vitamin D weekly for 8 weeks.

Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 6,000 IU of vitamin D daily for 8 weeks.

20 patients with high calcium (Ca) values in blood tests, patients with kidney and urinary stones, as well as patients who refuse to use vitamin D supplements will be included in the control group

Outcomes

Primary Outcome Measures

Hand grip strength
Measurement of both hands grip strength by Jamar dynamometer

Secondary Outcome Measures

Spinal cord İndependence 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).
Muscle thickness
Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.

Full Information

First Posted
May 17, 2020
Last Updated
February 11, 2021
Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04400747
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
January 4, 2021 (Actual)
Study Completion Date
January 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
25(OH)D, hand grip strength, Spinal cord injuries, muscle thickness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
weekly treatment group
Arm Type
Experimental
Arm Description
Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 50,000 IU of vitamin D weekly for 8 weeks.
Arm Title
daily treatment group
Arm Type
Experimental
Arm Description
Twenty patients with spinal cord injury with serum 25 (OH) D3 level less than 20 ng / ml will receive 6,000 IU of vitamin D daily for 8 weeks.
Arm Title
control group
Arm Type
No Intervention
Arm Description
20 patients with high calcium (Ca) values in blood tests, patients with kidney and urinary stones, as well as patients who refuse to use vitamin D supplements will be included in the control group
Intervention Type
Drug
Intervention Name(s)
Vitamin D3
Other Intervention Name(s)
cholecalciferol
Intervention Description
one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
Primary Outcome Measure Information:
Title
Hand grip strength
Description
Measurement of both hands grip strength by Jamar dynamometer
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Spinal cord İndependence Measurement (SCIM version 3)
Description
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).
Time Frame
8 weeks
Title
Muscle thickness
Description
Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18-60 years old Thoracic level chronic spinal cord injury A, B, C, D complete / incomplete patients according to ASIA classification 25 (OH) D3 level in serum is <20 ng / ml Complete muscle strength in upper extremity Exclusion Criteria: Individuals with chronic liver, kidney, respiratory and parathyroid disease Chronic constipation Patients who have recently used vitamin D Use of drugs that will affect vitamin D and Ca level (Thiazide group diuretics, statins) Acute inflammation (may show false low in vitamin D levels)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demet Ferahman, MD
Organizational Affiliation
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul Physical Medicine Rehabilitation Training & Research Hospital
City
İstanbul
ZIP/Postal Code
34173
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22710945
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.
Results Reference
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PubMed Identifier
8786732
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.
Results Reference
background
PubMed Identifier
27645263
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.
Results Reference
background
PubMed Identifier
21646368
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.
Results Reference
background
PubMed Identifier
16048137
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.
Results Reference
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Oral Colecalciferol Treatment in Spinal Cord Lesion

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