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

February 25, 2019 updated by: Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute

Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial

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

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 three intervention groups: 1.fortified bread+placebo,2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of bread and supplement or placebo every day for 2 months.

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

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

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 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 20 to 50 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: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fortified bread
daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo
Dietary supplement: fortified bread
50 g of fortified bread + placebo daily
Other Names:
  • FB
Experimental: supplement
daily intake of plain bread (50 g) plus supplement (1000 IU per tablet)
Dietary supplement: supplement
vitamin D supplement+ plain bread
Other Names:
  • SP
Placebo Comparator: placebo
daily intake of plain bread plus placebo
Dietary supplement: placebo
plain bread+placebo
Other Names:
  • PP

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 PTH (pg/mL)
Time Frame: 8 weeks
8 weeks
serum HDL (mg/dL)
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

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

January 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 3, 2015

First Submitted That Met QC Criteria

August 4, 2015

First Posted (Estimate)

August 5, 2015

Study Record Updates

Last Update Posted (Actual)

February 27, 2019

Last Update Submitted That Met QC Criteria

February 25, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 054-574

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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