Vitamin D injection versus oral vitamin D in adults with vitamin D deficiency

Comparative evaluation of aqueous vitamin D injection versus oral vitamin D in healthy individuals with vitamin D deficiency: A randomized active-controlled trial - NIL

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/07/055517

Enrollment

160

Registered

2023-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-05-27

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

Conditions

None listed

Interventions

Intervention1: Aqueous Vitamin D injection: 600000 IU single dose Control Intervention1: Vitamin D capsule: 60,000 IU once weekly for 10 weeks orally

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult, human subject aged from 18 to 65 years (inclusive both) with 25-hydroxyvitamin D [25(OH)D] 2. Not taken any Vitamin D supplementation in last 30 days 3. Willing to sign written informed consent form 4. No contraindications with the study medication with any previous medical or surgical history.

Exclusion criteria

Exclusion criteria: 1. Known history of hypersensitivity or idiosyncratic reaction to Cholecalciferol or any of its excipients 2. Known intake of heparin or other drugs that interfere with calcium metabolism. 3. Any psychiatric disorder, personality disorder, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study, or limit the ability to comply with protocol requirements 4. Any known medical illness (acute or chronic) 5. Pregnancy and lactation 6. Women intending to become pregnant

Design outcomes

Primary

Measure	Time frame
Serum 25-hydroxyvitamin DTimepoint: 0, 4, 8, 12 weeks	—

Secondary

Measure	Time frame
Safety evaluationTimepoint: 0, 4, 8, 12 weeks;Serum calciumTimepoint: 0, 4, 8, 12 weeks	—

Countries

India

Contacts

Public ContactDr Debasish Hota

AIIMS

pharm_debasish@aiimsbhubaneswar.edu.in9438884190

Outcome results