Effect of Vitamin d and Omega 3 on Osteocalcin

Not Applicable

Completed

• Conditions: Vitamin D Deficiency

• Registration Number: NCT04005612
• Lead Sponsor: Applied Science Private University

Brief Summary

Assessing the combined effect of omega-3 fatty acid and vitamin D 3 on plasma osteocalcin levels

Detailed Description

The data about effect of vitamin D3 (VD3) and omega-3 fatty acids(omega-3FA) on plasma levels of osteocalcin (OCN) are scarce and conflicting and nothing is published in the literature about the effect of the combination of VD3 and omega-3FA on the OCN levels.

This study was conducted to investigate effect of VD3 and omega-3FA alone and with each other on PLASMA OCN levels in females and males with vitamin D deficiency (VDD).

This randomized, controlled clinical trial was designed to test effects of 50,000 IU VD3 weekly and 300 mg omega-3FA daily for eight weeks,separately and with each other, on the plasma levels of OCN and 25-hydroxy vitamin D (25OHD).

This study was conducted during winter in 86 healthy Jordanian females and males with VDD with a mean age of (40± 10) years.

Fasting serum levels for 25OHD,OCN, PTH (parathyroid hormone),calcium, phosphate, ALT (alanine aminotransferase), and urea were assessed at baseline and the end of the trial .

Study Timeline

• Study First Submitted: 2019-07-01
• Study First Submitted QC: 2019-07-01
• Study First Posted: 2019-07-02
• Study Start: 2019-11-01
• Primary Completion: 2020-02-01
• Study Completion: 2020-02-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-12
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Medical diagnosis of vitamin D deficiency (VD < 30 ng / ml).

Exclusion Criteria

• People who previously diagnosed with any chronic disease such as kidney diseases were excluded from the study due to the effect of prolonged administration of VD3 on kidney stones formation.
• People with bone disorders also excluded.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
vitamin d3 levels	8 weeks	Plasma levels of 25-hydroxyvitamin D
osteocalcin levels	8 weeks	plasma osteocalcin levels

Secondary Outcome Measures

Name	Time	Method
PTH	8 weeks	Plasma concentrations of PTH
calcium	8 weeks	plasma Ca levels

Trial Locations

Locations (1)

Applied Science University; 🇯🇴 Amman, Jordan