Table 1.
Ongoing clinical trials exploring the effect of vitamin D supplementation in neurological diseases. AD Alzheimer’s disease; BMI body mass index; CDR Clinical Dementia Rating; CIS clinically isolated syndrome; EDSS Expanded Disability Status Scale; FA fatty acids; GMFCS Gross Motor Function Classification System; HbA1c haemoglobin A1c; IU international unit; PD Parkinson’s disease; RRMS relapsing-remitting multiple sclerosis; STN-DBS subthalamic nucleus-deep brain stimulation. To convert 25(OH)D from ng/mL to nmol/L the value is multiplied by 2.5.
| Formulation | Indication(s) | Status | Phase | Notes | References |
|---|---|---|---|---|---|
| Cholecalciferol | RRMS and serum vitamin D level below 25 ng/mL; age ≥ 18 years old | Recruiting | N/A | low dose vitamin D3 supplementation (800 IU daily for 6 months) or high dose vitamin D3 supplementation (50,000 IU weekly dose) |
NCT03610139 |
| Calcifediol or Cholecalciferol | RRMS and Vitamin D deficiency/insufficiency [25(OH)D < 30 ng/mL]; age ≥ 18 years old | Recruiting | IV | calcifediol 50 micrograms per day or cholecalciferol 50 micrograms per day, for 24 weeks | NCT05340985 |
| Vitamin D | AD; age 50 to 90; CDR 0.5 to 1 | Recruiting | N/A | Behavioural interventions (therapeutic lifestyles changes) and diet (intake of micronutrient supplements consisting of multivitamin, vitamin D, calcium, and phosphorus) | NCT03860792 |
| Cholecalciferol | CIS or RRMS; age 18 to 45; EDSS of 5.5 or less; patients must demonstrate features of a first typical optic neuritis within 21 days of recruitment | Recruiting | II | 5 days of high-dose oral vitamin D3 (50,000 IU daily × 5), followed by 85 days of moderate dose oral vitamin D3 (10,000 IU daily × 85 days) | NCT03302585 |
| Cholecalciferol | Patient has had a classic CIS within the past 90 days | Active, not recruiting | III | Patients will receive 100.000 IU of cholecalciferol every 14 days for a maximum of 24 months | NCT01817166 |
| Cholecalciferol | PD in STN-DBS treatment | Enrolling by invitation | N/A | Juvit D3 dosage based on the BMI: for BMI under 25–4000 IU/day; for BMI 25 to 30–5000 IU/day; for BMI over 30–6000 IU/day. |
NCT04768023 |
| Cholecalciferol | Painful diabetic neuropathy, insulin dependent diabetes or insulin independent diabetes; age 25 to 80 years; HbA1c level must be ≥6.5% |
Recruiting | N/A | single oral dose capsule 200,000 IU of Cholecalciferol | NCT05080530 |
| Cholecalciferol | episodic cluster headache as well as cluster periods that are predictable and have a duration of 6 weeks or greater and approxi-mately one attack daily minimum OR chronic cluster headache with approximately one attack daily |
Recruiting | III | Vitamin D + multi-vitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done. | NCT04570475 |
| Vitamin D | Episodic migraine without or without aura; age 20 to 65; baseline migraine days 4 to 15 days per month, blood level of vitamin D < 30 ng/mL at baseline | Recruiting | N/A | Omega-3 FA (first 4-week) plus Vitamin D (second 4-week) | NCT05449145 |
| Cholecalciferol | Cerebral palsy with spastic or mixed tone; GMFCS Level I-III (i.e., ambulatory); age 13 to 17 | Enrolling by invitation | N/A | 3 g β-hydroxy-β-methylbutyrate + 1000 IU of Vitamin D3 per day for 12 weeks | NCT05384951 |
| Vitamin D | Painful diabetic neuropathy (diagnosis based on validated Diabetic Neuropathy Symptoms and Diabetic Neuropathy Examination); low vitamin D status at baseline (<30 ng/mL) | Recruiting | III | Vitamin D 5000 IU Oral Tablet once daily for 8 weeks | NCT04689958 |
| 1,25(OH)2D | Friedreich’s Ataxia with confirmed genetic diagnosis | Active, not recruiting | IV | 1,25(OH)2D 0.25 mcg/24 h for a year, to evaluate the effects on the neurological symptoms. | NCT04801303 |