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A clinical trial to study the effect of vitamin D on improving the pain in chronic low back pain patients.

Improvement of Chronic Back Pain with Vitamin D supplementation: An open label; single arm study

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2014/03/004459
Enrollment
70
Registered
2014-03-10
Start date
Unknown
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

Health Condition 1: null- Chronic low back pain

Interventions

Intervention1: Active Vitamin-D3 60,000 IU/ 8Weeks: Induction phase: Active vitamin D3 in a dose of 60,000 IU/week for a period of 8 weeks will be given to the enrolled subjects (having serum vitamin

Sponsors

Department of Science Technology Chandigarh Administration
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Chronic low-back pain due to disc prolapse, lumbar spondylosis, and/or spinal stenosis, for at least 3 month refractory to conservative or interventional therapies, Documented low serum 25(OH)D3 levels (

Exclusion criteria

Exclusion criteria: Patient of chronic low back pain having medical conditions requiring calcium or vitamin D supplementation (i.e., osteoporosis) Diabetes, neurological disease, History of gastric ulcers or intestinal bleeding or alcohol or drug abuse. Evidence of renal disease (Se. creatinine > 1.5), liver disease (deranged LFT). Pregnant and lactating mothers and women intending pregnancy. Evidence of other causes for neuropathy and painful conditions. Epilepsy, psychiatric and substance abuse. Patients taking Vit-D supplements during the past three months.

Design outcomes

Primary

MeasureTime frame
Number of patients achieving at least 50% pain relief as compared to the baseline pain intensityTimepoint: 2 months

Secondary

MeasureTime frame
1. Overall VAS 2. Improvement in MODQ from baseline 3. Decrement in rescue medication Timepoint: Baseline and 1, 2, 3, 4 and 6 months

Countries

India

Contacts

Public ContactDr Babita Ghai

Post Graduate Institute of Medical Education and Research, Sector-12,Chandigarh, India-160012

ghaibabita@hotmail.com09914209533

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Mar 4, 2026