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

NCT ID: NCT02696590

Last Updated: 2016-03-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-31
• Study Completion Date: 2015-12-31

Brief Summary

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.

Detailed 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.

Conditions

Relapsing Remitting Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MS patients injectable Vitamin D3

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

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

MS patients orally Vitamin D3

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.

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

Healthy groups Injectable Vitamin D3

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

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

Healthy groups Vitamin D3 orally

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

Interventions

Vitamin D3

two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

cholecalciferol

Eligibility Criteria

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

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Isfahan University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Leila Dehghani

assistant prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Masoud Etemadifar, professor

Role: STUDY_DIRECTOR

Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran

Locations

Alzahra Hospital

Isfahan, Isfahan, Iran

Countries

Iran

Other Identifiers

Isfahan MS Society

Identifier Type: -

Identifier Source: org_study_id