Role of Vitamin D in Treatment of Lumbar Disc Herniation: Pain and Sensory Aspects

Clinical trial to evaluate the effect of vitamin D supplementation on discogenic pain and sensory deficits associated with cases afflicted with lumbar disc herniation

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014050317534N1

Enrollment

380

Registered

2014-06-05

Start date

2015-01-01

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

Condition 1: Lumbar Disc Herniation. Condition 2: Lumbar Disc Herniation. Other specified intervertebral disc displacement Lumbar and other intervertebral disc disorders with radiculopathy

Interventions

Intervention 1: Name of the drug: Ampoule 25 Hydroxy Vitamin D3 Chemical composition: 25 Hydroxy Vitamin D3 Concentration: 300000 International Unit in 0ne ml. Dosage: One Ampoule Intramuscular inject

Treatment - Other

Treatment - Drugs

Placebo

Name of the drug: Ampoule 25 Hydroxy Vitamin D3 Chemical composition: 25 Hydroxy Vitamin D3 Concentration: 300000 International Unit in 0ne ml. Dosage: One Ampoule Intramuscular injection Number

Deficient Vitamin D level (less than 10ng/ml)

Insufficient vitamin D level (less than 32ng/ml)

A single-dose of 300 000 IU of 25 Hydroxy vitamin D3 (1 ml) will be injected intramuscularly.

A single-dose of distilled water (1 ml) will be injected intramuscularly.

Optimum vitamin D level group (32-50ng/ml)

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria: 1) No coexistent or preexisting spine pathology (e.g. Spondylolisis, Spondylolisthesis, Infection, Tumors, Fracture); 2) Single level lumbar disc herniation; 3) Discogenic pain duration from onset up physician evaluation: less than 8 weeks; 4) Compliance with study protocol; 5) Normal Lab studies; Exclusion Criteria: 1) Daily supplementation intake of more than 800 IU of vitamin D; 2) Serum calcium level more than 10.5 md/dl; 3) Hypercalciuria ( spot urine calcium creatinin ratio more than 0.4); 4) Lymphoma, Sarcoidosis, TB, Hyperparathyroidism, Celiac disease, malabsorption syndromes; 5) Hx of renal stone; 6) Hx of inflammatory back pain; 7) Impaired renal function tests (GFR less than 30); 8) Impaired hepatic function tests; 9) Abnormal Serum Phosphorus, Alkaline phosphatase and Parathyroid hormone values; 10) FBS more than 126; 11) Previous spine surgery; 12) Hx of trauma; 13) Taking Anticonvulsant, Anti-TB medications or vitamin D analogs; 14) Cauda Equina syndrome that requires emergency surgical decompression.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Pain. Timepoint: One initial and one final assessment will be performed at clinic.during 15-day conduction period, individuals will be contacted by phone every 3 days to comlete the questionnaires. Method of measurement: Visual analoque score for low back pain and radicular pain severity.	—

Secondary

Measure	Time frame
Sensory deficits. Timepoint: One initial and one final assessment will be carried out at clinic.During 15-day conduction period, individuals will be contacted by phone every 3 days to comlete the questionnaires. Method of measurement: Mc-Gill questionnaire.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahsa Sedighi

Shiraz University Of Medical Science

sedighi.mahsan@gmail.com+98 71 1233 0161

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 19, 2026