Effect of Vitamin d and Omega 3 on Osteocalcin

Vitamin D Deficiency Clinical Trial

Official title:

Assessing the Combined Effect of Omega-3 Fatty Acid and Vitamin D3 on Plasma Osteocalcin Levels : a Randomized Controlled Trial in Males and Females With Vitamin D Deficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04005612
• Other study ID #: DRGS-2014-2015-165-3
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: February 1, 2020

Study information

• Verified date: July 2020
• Source: Applied Science Private University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 1, 2020
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Vitamin D Deficiency

Intervention

Dietary Supplement:
• vitamin D3
50,000 IU VD3 / week for 8 weeks
• omega-3 fatty acid
300 mg of omega 3-FA once daily for 8 weeks
• vitamin D3 and omega-3 fatty acid
50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

Other:
• control
no intervention

Locations

Country	Name	City	State
Jordan	Applied Science University	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Applied Science Private University

Country where clinical trial is conducted

Jordan, 

References & Publications (1)

Holick MF, Chen TC. Vitamin D deficiency: a worldwide problem with health consequences. Am J Clin Nutr. 2008 Apr;87(4):1080S-6S. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vitamin d3 levels	Plasma levels of 25-hydroxyvitamin D	8 weeks
Primary	osteocalcin levels	plasma osteocalcin levels	8 weeks
Secondary	PTH	Plasma concentrations of PTH	8 weeks
Secondary	calcium	plasma Ca levels	8 weeks