. 2021 Dec 16;11(12):e053951. doi: 10.1136/bmjopen-2021-053951

Table 1.

Eligibility criteria

Inclusion criteria	Exclusion criteria
Informed Consent to the study as documented by a signature. Chronic (>3 years) traumatic or non-traumatic spinal cord injury a vertebral lesion level of C4 or below. Between 18–60 years old. Wheelchair dependency during activities of daily living, defined by a score of 0–2 in the Spinal Cord Independence Measure, subsection ‘Mobility in the house’. An insufficient vitamin D status (≤75 nmol/L) at the first visit.	Contraindications to the investigational product, including known hypersensitivity or allergy to the cholecalciferol or alcohol solution. Clinically relevant disorders, including renal dysfunction, hepatic dysfunction, cardiovascular disease, lung disease, diabetes, blood disease, parathyroid disease, cancer, depression, alcohol abuse and/or the intake of significant concomitant medication (including osteoporosis treatment and benzothiadiazide derivatives). This will be assessed on an individual basis. Grade 3 or 4 pressure injuries. Women who are pregnant or planning to become pregnant during the study period. Women who are breast feeding. Fractures in both arms and/or both legs within the last 5 years. Intake of >400 IU/day vitamin D supplementation during the last 12 months before recruitment or during the study. Visiting a country with increased sun exposure (below the 37th parallel north, that is, the southern hemisphere) within 1 month before enrolment or during the study. Inability to understand or decide on study participation (ie, make an informed consent) and to adhere to the study protocol, for example, due to language or psychological problems.

Inclusion criteria

Exclusion criteria

Informed Consent to the study as documented by a signature.
Chronic (>3 years) traumatic or non-traumatic spinal cord injury a vertebral lesion level of C4 or below.
Between 18–60 years old.
Wheelchair dependency during activities of daily living, defined by a score of 0–2 in the Spinal Cord Independence Measure, subsection ‘Mobility in the house’.
An insufficient vitamin D status (≤75 nmol/L) at the first visit.

Contraindications to the investigational product, including known hypersensitivity or allergy to the cholecalciferol or alcohol solution.
Clinically relevant disorders, including renal dysfunction, hepatic dysfunction, cardiovascular disease, lung disease, diabetes, blood disease, parathyroid disease, cancer, depression, alcohol abuse and/or the intake of significant concomitant medication (including osteoporosis treatment and benzothiadiazide derivatives). This will be assessed on an individual basis.
Grade 3 or 4 pressure injuries.
Women who are pregnant or planning to become pregnant during the study period.
Women who are breast feeding.
Fractures in both arms and/or both legs within the last 5 years.
Intake of >400 IU/day vitamin D supplementation during the last 12 months before recruitment or during the study.
Visiting a country with increased sun exposure (below the 37th parallel north, that is, the southern hemisphere) within 1 month before enrolment or during the study.
Inability to understand or decide on study participation (ie, make an informed consent) and to adhere to the study protocol, for example, due to language or psychological problems.