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Spinal Cord InjuryNCT04400747

Oral Colecalciferol Treatment in Spinal Cord Lesion

A study testing Vitamin D3 in people with Spinal Cord Injury, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Spinal Cord Injury
What is being tested?
Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Sep 2020to 4 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Physical Medicine Rehabilitation Training & Research Hospital

    Istanbul, 34173

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the 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.

Being tested
Vitamin D3
Keywords
25(OH)D, hand grip strength, Spinal cord injuries, muscle thickness
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin D3Drug

    Also called cholecalciferol

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

Study groups in NCT04400747
Study groupRoleWhat they receive
weekly treatment groupExperimentalTwenty 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.
Receives: Drug: Vitamin D3
daily treatment groupExperimentalTwenty 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.
Receives: Drug: Vitamin D3
control groupNo intervention20 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hand grip strength

    Measurement of both hands grip strength by Jamar dynamometer

    Measured: 8 weeks

Secondary outcomes (2)

  1. 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).

    Measured: 8 weeks

  2. Muscle thickness

    Both sides biceps brachii and triceps muscle thicknesses will be measured by ultrasonography.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2020
  2. Study start1 Sep 2020
  3. Primary completion4 Jan 2021
  4. Study completion4 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04400747
Sponsor's protocol ID
PMRIST
Status last verified
Feb 2021
First submitted
17 May 2020
Last updated
12 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22710945

  • 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.

    PubMed 8786732

  • 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.

    PubMed 27645263

  • 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.

    PubMed 21646368

  • 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.

    PubMed 16048137

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin D3 in people with Spinal Cord Injury, run by Istanbul Physical Medicine Rehabilitation Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hand grip strength (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04400747, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.

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