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Completed

NCT Number: NCT04400747

Oral Colecalciferol Treatment in Spinal Cord Lesion

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.

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Key information

Conditions

Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Vitamin D3

Drug

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

Other names: cholecalciferol

Primary outcomes

  1. Hand grip strength

    Time frame: 8 weeks

    Measurement of both hands grip strength by Jamar dynamometer

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Other Gov

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 26, 2020
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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