Effects of adjunct low-dose vitamin D on relapsing-remitting multiple sclerosis progression: Preliminary findings of a randomized, placebo-controlled trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT201104166202N1

Enrollment

Registered

2011-04-29

Start date

2009-04-01

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

relapsing-remitting multiple sclerosis. Multiple sclerosis

Interventions

Intervention 1: Adjunct Calcitriol, (Trade name Zavitrol, Zahravi Pharm. Co. Tabriz, Iran), 0.25 µg per day (twice a day, orally before meals), increased to 0.5 µg/day after 2 weeks and will continue

Treatment - Drugs

Placebo

Adjunct Calcitriol, (Trade name Zavitrol, Zahravi Pharm. Co. Tabriz, Iran), 0.25 µg per day (twice a day, orally before meals), increased to 0.5 µg/day after 2 weeks and will continue for 12- months a

Placebo capsules, twice a day, orally before meals for 12-months as well as routine MS medications.

Eligibility

Sex/Gender

All

Age

15 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: either sex, age between 15 and 60 years, diagnosis of definite RRMS with a MRI, clinical or laboratory, mean (standard deviation) duration equal to 4.3 (2.2) years, range 1-12 years, stable neurological functioning for at least one month prior to the study entry, EDSS score =6, serum 25-hydroxyvitamin D level> 40 ng/ml, willingness to continue current medications for the duration of the study Exclusion criteria: evidence of substantial abnormalities in neurological, psychiatric, cardiac, endocrinological, hematologic, hepatic, renal, or metabolic functions, use of digitalis, vitamin D supplement, any condition predisposing to hypercalcemia, nephrolithiasis, renal insufficiency, pregnancy as determined by history, physical examination and screening blood tests. secondary-progressive and primary-progressive MS, Women in child-bearing age with no clinically-accepted method of contraception

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Expanded Disability Status Scale (EDSS). Timepoint: 2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12. Method of measurement: Clinical evaluation by a qualified neurologist.	—

Secondary

Measure	Time frame
Number of relapses. Timepoint: 2-months interval, at the baseline and months 2, 4, 6, 8, 10 and 12. Method of measurement: Clinical evaluation by a qualified neurologist.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohsen Janghorbani

Isfahan University of Medical Sciences

janghorbani@hlth.mui.ac.irjanghorbani@yahoo.com+98 31 1233 4893

Outcome results

None listed

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