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Oral Colecalciferol Treatment in Spinal Cord Lesion

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ClinicalTrials.gov Identifier: NCT04400747
Recruitment Status : Not yet recruiting
First Posted : May 26, 2020
Last Update Posted : May 26, 2020
Sponsor:
Information provided by (Responsible Party):
Demet Ferahman, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Drug: Vitamin D3 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
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
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : April 30, 2021
Estimated Study Completion Date : August 12, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: weekly treatment group
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.
Drug: Vitamin D3
one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
Other Name: cholecalciferol

Experimental: daily treatment group
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.
Drug: Vitamin D3
one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
Other Name: cholecalciferol

No Intervention: control group
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



Primary Outcome Measures :
  1. Hand grip strength [ Time Frame: 8 weeks ]
    Measurement of both hands grip strength by Jamar dynamometer


Secondary Outcome Measures :
  1. Spinal cord İndependence Measurement (SCIM version 3) [ Time Frame: 8 weeks ]
    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).

  2. Muscle thickness [ Time Frame: 8 weeks ]
    Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400747


Contacts
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Contact: Demet Ferahman, MD +905364702930 ddincay@hotmail.com
Contact: Kadriye Önes, Prof +905322432870 kadriyeones@yahoo.com

Sponsors and Collaborators
Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Investigators
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Principal Investigator: Demet Ferahman, MD Istanbul Physical Medicine Rehabilitation Training & Research Hospital
Publications:
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Responsible Party: Demet Ferahman, Assistant doctor, Istanbul Physical Medicine Rehabilitation Training and Research Hospital
ClinicalTrials.gov Identifier: NCT04400747    
Other Study ID Numbers: PMRIST
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: May 26, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Demet Ferahman, Istanbul Physical Medicine Rehabilitation Training and Research Hospital:
25(OH)D
hand grip strength
Spinal cord injuries
muscle thickness
Additional relevant MeSH terms:
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Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Vitamin D
Cholecalciferol
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents