Oral Colecalciferol Treatment in Spinal Cord Lesion

NCT04400747 | Completed

• 1 other identifier: PMRIST
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

25(OH)D; hand grip strength; Spinal cord injuries; muscle thickness

Outcome Measures

Primary Outcomes (1)

• Hand grip strength

  Measurement of both hands grip strength by Jamar dynamometer

  8 weeks

Secondary Outcomes (2)

• Spinal cord İndependence Measurement (SCIM version 3)

  8 weeks

• Muscle thickness

  8 weeks

Study Arms (3)

weekly treatment group

EXPERIMENTAL

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

daily treatment group

EXPERIMENTAL

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

control group

NO INTERVENTION

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

Interventions

Vitamin D3 DRUG

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

Also known as: cholecalciferol

daily treatment group; weekly treatment group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• years old
• Thoracic level chronic spinal cord injury
• A, B, C, D complete / incomplete patients according to ASIA classification
• (OH) D3 level in serum is \<20 ng / ml
• Complete muscle strength in upper extremity

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training & Research Hospital

Istanbul, 34173, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 22710945 BACKGROUND

• 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.

  PMID: 8786732 BACKGROUND

• 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.

  PMID: 27645263 BACKGROUND

• 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.

  PMID: 21646368 BACKGROUND

• 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.

  PMID: 16048137 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Demet Ferahman, MD

  Istanbul Physical Medicine Rehabilitation Training & Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant doctor

Model Details: 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.

Study Record Dates

• First Submitted: May 17, 2020
• First Posted: May 26, 2020
• Study Start: September 1, 2020
• Primary Completion: January 4, 2021
• Study Completion: January 4, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)