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Completed

NCT Number: NCT04005612

Effect of Vitamin d and Omega 3 on Osteocalcin

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

Completed

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

22 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Science University

Amman, Jordan

About this study

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 .

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vitamin D3

Dietary Supplement

50,000 IU VD3 / week for 8 weeks

Omega-3 fatty acid

Dietary Supplement

300 mg of omega 3-FA once daily for 8 weeks

vitamin D3 and omega-3 fatty acid

Dietary Supplement

50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks

Control

Other

no intervention

Primary outcomes

  1. vitamin d3 levels

    Time frame: 8 weeks

    Plasma levels of 25-hydroxyvitamin D

  2. osteocalcin levels

    Time frame: 8 weeks

    plasma osteocalcin levels

Secondary outcomes

  1. PTH

    Time frame: 8 weeks

    Plasma concentrations of PTH

  2. calcium

    Time frame: 8 weeks

    plasma Ca levels

Sponsors and collaborators

Lead sponsor

Applied Science Private University

Other

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 2, 2019
Registry last updated
Jul 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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