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Vitamin D as an adjuvant therapy to Amitriptyline in migraine

Effectiveness of Vitamin D as adjuvant to Amitriptyline therapy in migraine - A single blinded Randomized placebo controlled trial in a tertiary care institute

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036180
Enrollment
200
Registered
2021-09-02
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: G439- Migraine, unspecified

Interventions

Intervention1: vitamin D: 60,000 IU weekly once for 3 months Control Intervention1: Placebo: Weekly once for 3 months

Sponsors

All India Institute of Medical Sciences Bhubaneswar
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Migraine as per diagnostic criteria(ICDH-II) and who is on tablet amitriptyline of 25 mg dosage for at least 1 month 2. Written informed consent obtained prior to any screening procedures

Exclusion criteria

Exclusion criteria: 1. Chronic systemic disease rheumatologic, gastrointestinal, liver and kidney disease. 2. Those with diseases causing immobilization and malabsorption. 3. Those with incomplete laboratory results, those who had taken other prophylactic or other regular medication for migraine except amitriptyline 4. Those receiving any medication affecting bone metabolism (vitamin D, calcium, steroids, or nonsteroidal anti-inflammatory drugs) 5. Chronic neurological and psychiatric problems (epilepsy, altered behavior and school performance, mental retardation, focal neurological deficits)

Design outcomes

Primary

MeasureTime frame
1. To study the efficacy of vitamin D supplementation in reducing frequency and duration in migraine patients who is on amitriptyline 25 mgTimepoint: Baseline, Day 30 and Day 90

Secondary

MeasureTime frame
NATimepoint: NA

Countries

India

Contacts

Public ContactDr Anupama Behera

All India Institute of Medical Sciences Bhubaneswar

anupama6799@gmail.com9437800568

Outcome results

None listed

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