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Trial record 13 of 28 for:    multiple sclerosis | vitamin D

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

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ClinicalTrials.gov Identifier: NCT02696590
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : March 2, 2016
Sponsor:
Information provided by (Responsible Party):
Leila Dehghani, Isfahan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Relapsing Remitting Multiple Sclerosis Dietary Supplement: Vitamin D3 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isfahan University of Medical Sciences
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Dietary Supplement: Vitamin D3
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Other Name: cholecalciferol

Experimental: 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.
Dietary Supplement: Vitamin D3
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Other Name: cholecalciferol

Active Comparator: 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
Dietary Supplement: Vitamin D3
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Other Name: cholecalciferol

Active Comparator: 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.
Dietary Supplement: Vitamin D3
two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
Other Name: cholecalciferol




Primary Outcome Measures :
  1. Serum concentration of 25(OH)D [ Time Frame: Two Weeks ]


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Ages Eligible for Study:   23 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696590


Locations
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Iran, Islamic Republic of
Alzahra Hospital
Isfahan, Iran, Islamic Republic of, 81745319
Sponsors and Collaborators
Isfahan University of Medical Sciences
Investigators
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Study Director: Masoud Etemadifar, professor Isfahan MS Society, Isfahan University of Medical Sciences, Isfahan, Iran

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Responsible Party: Leila Dehghani, assistant prof, Isfahan University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02696590     History of Changes
Other Study ID Numbers: Isfahan MS Society
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: March 2, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Vitamin D
Vitamins
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ergocalciferols
Cholecalciferol
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents