Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: A Three Arm, Randomized, Double Blind, Placebo Controlled, Multicenter, Phase II Study to Evaluate the Efficacy of Vigantol® Oil as Add on Therapy in Subjects With Relapsing Remitting Multiple Sclerosis Receiving Treatment With 44mg Tiw of Rebif®
Brief Summary: The drug being tested is called VigantOL® oil - a very effective form of Vitamin D hormone supplement (cholecalciferol). Low levels of Vitamin D have been described to be associated with a higher risk of developing Multiple Sclerosis (MS), and it is known that up to 90% of patients with Multiple Sclerosis have Vitamin D deficiency.

Rebif® is known to be an effective treatment for slowing down the progression of MS. The purpose of this research trial is to evaluate if VigantOL® oil on top of Rebif® has any benefit on the progression of MS compared to Rebif® and placebo.

Disease activity will be assessed by clinical examination and Magnetic Resonance Imaging (MRI). The planned study treatment duration for each study participant is 48 weeks, and the study consists of a total of 8 visits. Study participants who are already passed Week 48 at the time of approval of Protocol Amendment 5 will have a study duration of 96 weeks and a total of 12 visits.

During the study, the participant will undergo physical examination, neurological assessments, safety assessments, blood tests and urinalysis (including pregnancy tests).


Options:
A: Arm Label: Treatment; Type: EXPERIMENTAL; Interventions: Dietary Supplement: Vitamin D3 | Arm Label: Control; Type: OTHER; Interventions: Dietary Supplement: Vitamin D3 | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Treatment | Intervention Type: DIETARY_SUPPLEMENT; Name: Vitamin D3; Assigned to Arm(s): Control
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: Colecalciferol | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo capsules | Intervention Type: DRUG; Name: Colecalciferol; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: Placebo capsules; Assigned to Arm(s): 2
C: Arm Label: VigantOL® oil; Type: EXPERIMENTAL; Interventions: Drug: VigantOL oil plus interferon beta-1a (Rebif) | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo plus interferon beta-1a (Rebif) | Arm Label: Rebif; Type: EXPERIMENTAL; Interventions: Biological: Interferon beta-1a (Rebif®) alone | Intervention Type: DRUG; Name: VigantOL oil plus interferon beta-1a (Rebif); Assigned to Arm(s): VigantOL® oil | Intervention Type: DRUG; Name: Placebo plus interferon beta-1a (Rebif); Assigned to Arm(s): Placebo | Intervention Type: BIOLOGICAL; Name: Interferon beta-1a (Rebif®) alone; Assigned to Arm(s): Rebif
D: Arm Label: 1; Type: ACTIVE_COMPARATOR; Interventions: Dietary Supplement: cholecalciferol, Dietary Supplement: calcium carbonate | Arm Label: 2; Type: PLACEBO_COMPARATOR; Interventions: Dietary Supplement: calcium carbonate | Intervention Type: DIETARY_SUPPLEMENT; Name: cholecalciferol; Assigned to Arm(s): 1 | Intervention Type: DIETARY_SUPPLEMENT; Name: calcium carbonate; Assigned to Arm(s): 1, 2

Answer: C