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

Isfahan University of Medical Sciences

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696590
Enrollment
200
Registered
2016-03-02
Start date
2015-07-31
Completion date
2015-12-31
Last updated
2016-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Remitting Multiple Sclerosis

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.

Interventions

DIETARY_SUPPLEMENTVitamin D3

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

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
23 Years to 59 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Serum concentration of 25(OH)DTwo Weeks

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026