High Dose Oral Versus Intramuscular Vitamin D3 Supplementation In Multiple Sclerosis Patients

Isfahan University of Medical Sciences

Status: Completed

Conditions: Relapsing Remitting Multiple Sclerosis

Treatments: Dietary Supplement: Vitamin D3

Study type: Interventional

Funder types: Other

Identifiers

NCT02696590

Isfahan MS Society

Details and patient eligibility

About

This study aimed to evaluate oral and injectable routes in treatment of hypovitaminosis D in multiple sclerosis (MS) patients. The investigators aimed to assess the efficacy of each method, using the same Mega dose of 600 000 IU D3, in achieving normal serum 25(OH)D level, the durability of the response, the practicality and the possible toxicity.

Full description

Ultraviolet sunlight is too low to produce adequate amounts of vitamin D3, and vitamin D insufficiency lasting 4 to 6 months of the year at latitudes of ≥42° is common in individuals with low vitamin D intake. Vitamin D has strong immunoregulatory effects, and vitamin D supplementation prevents experimental autoimmune encephalomyelitis (EAE), an autoimmune disease in animals that is used as a model of MS.

Recently, emerging data from epidemiologic studies suggest that vitamin D may play an important role in the progression of the development of MS. A longitudinal study in pediatric MS showed a 34% lower risk of relapse for every 10 ng/ml higher 25-hydroxyvitamin D level. A similar magnitude of reduced relapse risk was later reported in an adult MS cohort. Higher vitamin D levels have also been shown to be associated with less subsequent inflammatory MS activity on brain magnetic resonance imaging (MRI). Finally, studies have demonstrated that patients have lower vitamin D levels during MS relapses.

Enrollment: 200 patients

Sex: All

Ages: 23 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• with serum 25(OH)D3 concentration ≤ 20 ng/ml

Exclusion criteria

• hypercalcaemia, primary hyperparathyroidism, Paget disease, thyrotoxicosis, pregnancy, active malignancy, hypercalciuria, history of liver disease, renal insufficiency, clinically apparent malabsorption syndrome, using drugs containing vitamin D products, calcium, estrogen and drugs known to affect vitamin D metabolism (anticonvulsants, glucocorticoids) or receiving any form of supplements containing vitamin D during last 6 months.
• Participants with serum 25(OH)D concentration≥ 20 ng/ml

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 4 patient groups

MS patients injectable Vitamin D3

Experimental group

Description:

MS patients who received injectable form of Vitamin D3, received 600.000 IU Intramuscular vitamin D3 injection, in two weeks; 300.000 IU at the study entry and 300.000 IU in second week

Treatment:

Dietary Supplement: Vitamin D3

MS patients orally Vitamin D3

Experimental group

Description:

received the same total dose of 600 000 IU D3 in two weeks, in the form of twelve pearls, each containing 50 000 IU D3 as follows: the first pearl was delivered at study entry, followed by one pearl each day for another 11 Days.

Treatment:

Dietary Supplement: Vitamin D3

Healthy groups Injectable Vitamin D3

Active Comparator group

Description:

who received injectable form of Vitamin D3, received 600.000 IU Intramuscular vitamin D3 injection, in two weeks; 300.000 IU at the study entry and 300.000 IU in second week

Treatment:

Dietary Supplement: Vitamin D3

Healthy groups Vitamin D3 orally

Active Comparator group

Description:

received the same total dose of 600 000 IU D3 in two weeks, in the form of twelve pearls, each containing 50 000 IU D3 as follows: the first pearl was delivered at study entry, followed by one pearl each day for another 11 Days.

Treatment:

Dietary Supplement: Vitamin D3