drugset / Trial / NCT04400747

Oral Colecalciferol Treatment in Spinal Cord Lesion

NCT04400747

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2020-09-01
Primary completion
2021-01-04
Completion
2021-01-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cholecalciferol Other / unclassified 6000 iu Oral
Subject Cholecalciferol Other / unclassified 50000 iu Oral

Indications