Evaluation Of Efficacy Of Nanoparticle Vitamin D In Patients With Vitamin D deficiency

Phase 4

Completed

• Conditions: Health Condition 1: null- Patients With Documented Deficiency Or Insufficiency Of Vitamin D

• Registration Number: CTRI/2016/09/007282
• Lead Sponsor: C Maneks Nursing Home and Polyclinic

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

Adult male or female patients aged 18 to 65 years of age

Patients with documented deficiency or insufficiency of vitamin D less than 30 ng per ml

Participants should have the ability to understand the requirements of the study

Participants willing to abide by the study restrictions and return for the required assessments

Exclusion Criteria

Patients less than 18 years of age

Patients with uncontrolled diabetes mellitus

Pregnant and lactating women

Patients with known hypersensitivity to Vitamin D supplement

Patients on medications interfering with Vitamin D metabolism

Patients with history of malabsorption kidney stones hypoparathyroidism or growth hormone deficiency

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of a nanoparticle based vitamin D formulation in correcting the Vitamin D levels after a weekly therapy for 8 weeksTimepoint: 8weeks

Secondary Outcome Measures

Name	Time	Method
Profile of patients with Vitamin D deficiency and pattern of repletion.Patients global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapy.Physician global assessment of efficacy on a 5point scale of Excellent Good Moderate Poor and Worst response will be assessed by the patients at the end of therapyTimepoint: 8weeks