Assessment of the Efficacy of Vitamin D-fortified Oil in Healthy Adults

January 31, 2019 updated by: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute

Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial

The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sixty apparently healthy subjects will be selected. Participants who are receiving vitamin D, calcium or omega-3 supplements within the last three months will be excluded. Subjects will be assigned randomly to one of the two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months.

At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 to 60 years
  • healthy subjects
  • no receiving vitamin D or omega-3 supplement in past 3 months

Exclusion Criteria:

- receiving vitamin D or omega-3 supplement during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fortified oil
daily intake of fortified sunflower oil (700IU vitamin D/ 35g)
Dietary supplement: fortified oil
35 g fortified sunflower oil
Placebo Comparator: control
daily intake of plain oil
Dietary supplement: Placebo
plain oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
25-hydroxyvitamin D (nmol/L)
Time Frame: 8 weeks
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
serum glucose (mg/dL)
Time Frame: 8 weeks
8 weeks
serum triglyceride (mg/dL)
Time Frame: 8 weeks
8 weeks
serum total cholesterol (mg/dL)
Time Frame: 8 weeks
8 weeks
serum LDL
Time Frame: 8 weeks
8 weeks
serum HDL
Time Frame: 8 weeks
8 weeks
serum PTH (pg/mL)
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Nutrition and Food Technology Institute

Investigators

  • Study Chair: Tirang R. Neyestani, PhD, Laboratory of Nutrition Research, National Nutrition and Food Technology Research Institute (NNFTRI) and Faculty of Nutrition Science and Food Technology, Shahid Beheshti University of Medical Sciences, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

January 31, 2019

First Submitted That Met QC Criteria

January 31, 2019

First Posted (Actual)

February 1, 2019

Study Record Updates

Last Update Posted (Actual)

February 1, 2019

Last Update Submitted That Met QC Criteria

January 31, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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