Relationship between serum level of vitamin-D3 and Expanded Disability Status Scale (EDSS) changes before and 8 weeks after methylprednisolone pulse therapy in multiple sclerosis (MS) patients

Evaluation of serum level of 25-hydroxy vitamin-D on Multiple Sclerosis attack under treatment with methyl prednisolone pulse on Sina Hospital

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201305281859N7

Enrollment

Registered

2015-10-17

Start date

2013-06-21

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Multiple Sclerosis. Disseminated Multiple Sclerosis

Interventions

Intervention 1: Amp vitamin-D3 ,chemical formulation active vitamin-D3 (calciteriol) , 300000 IU / day and single dose, intramuscular, made in Osva Pharmaceutical company in Islamic Republic Of Iran,

Treatment - Drugs

Amp vitamin-D3 ,chemical formulation active vitamin-D3 (calciteriol) , 300000 IU / day and single dose, intramuscular, made in Osva Pharmaceutical company in Islamic Republic Of Iran, not having gener

In 20 patients with low levels of vitamin D 3 whom are selected based on random numbers table , on the last day of 5 days pulse therapy , vitamin D 3 ampule will not be injected. They will be examined

In 20 patients with sufficient levels of vitamin D 3, therapy will not be given. They will be examined based on EDSS changes 8 weeks after pulse therapy.

In 20 patients with low levels of vitamin D 3 whom are selected based on random numbers table , on the last day of 5 days pulse therapy , vitamin D 3 ampule will be injected. They will be examined bas

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: 1- Patients with multiple sclerosis based on McDonalds Criteria. 2- Patients type relapsing-remitting (RRMS). 3-EDSS less than 5 before attack. 4-Less than 5 years after MS diagnosis. 5-Less than 5 attacks in the duration of MS diagnosis. Exclusion criteria: 1- Association with any diseases such as liver diseases, renal diseases, bone marrow disfunction, sarcoidosis, renal stone,hypercalcemia. 2-pregnancy or breast feeding. 3-Using drugs such as hydrochlorothiazide, phenytoin, barbiturate, digital.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The rate of recovery after attack. Timepoint: Before intervention and two months after intervention. Method of measurement: Physical examination done by neurologist and using Expanded Disability Status Scale (EDSS).	—

Secondary

Measure	Time frame
Expanded Disability Status Scale (EDSS). Timepoint: Before intervention and two months after intervention. Method of measurement: Physical examination done by neurologist based on revised Mc-Donald (2010).;Serum level of 25-hydroxy vitamin-D3. Timepoint: Before intervention and two months after intervention. Method of measurement: Blood test.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Shadi Assefi

Sina Hospital

sh.assefi@gmail.com+98 21 6634 8571

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026