NCT02696590

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
Last Updated

March 2, 2016

Status Verified

February 1, 2016

Enrollment Period

4 months

First QC Date

February 18, 2016

Last Update Submit

March 1, 2016

Conditions

Relapsing Remitting Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Serum concentration of 25(OH)D

    Two Weeks

Study Arms (4)

MS patients injectable Vitamin D3

EXPERIMENTAL

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

MS patients orally Vitamin D3

EXPERIMENTAL

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

Healthy groups Injectable Vitamin D3

ACTIVE COMPARATOR

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

Healthy groups Vitamin D3 orally

ACTIVE COMPARATOR

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

Interventions

Vitamin D3DIETARY_SUPPLEMENT

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

Also known as: cholecalciferol
Healthy groups Injectable Vitamin D3Healthy groups Vitamin D3 orallyMS patients injectable Vitamin D3MS patients orally Vitamin D3

Eligibility Criteria

Age23 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alzahra Hospital

Isfahan, Isfahan, 81745319, Iran

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Study Officials

  • Masoud Etemadifar, professor

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant prof

Study Record Dates

First Submitted

February 18, 2016

First Posted

March 2, 2016

Study Start

July 1, 2015

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

March 2, 2016

Record last verified: 2016-02

Locations

IR(1)