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

NCT ID: NCT02516254

Last Updated: 2019-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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fortified bread

daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo

Group Type EXPERIMENTAL

fortified bread

Intervention Type DIETARY_SUPPLEMENT

50 g of fortified bread + placebo daily

supplement

daily intake of plain bread (50 g) plus supplement (1000 IU per tablet)

Group Type EXPERIMENTAL

supplement

Intervention Type DIETARY_SUPPLEMENT

vitamin D supplement+ plain bread

placebo

daily intake of plain bread plus placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DIETARY_SUPPLEMENT

plain bread+placebo

Interventions

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fortified bread

50 g of fortified bread + placebo daily

Intervention Type DIETARY_SUPPLEMENT

supplement

vitamin D supplement+ plain bread

Intervention Type DIETARY_SUPPLEMENT

placebo

plain bread+placebo

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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FB SP PP

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Nutrition and Food Technology Institute

OTHER

Sponsor Role lead

Responsible Party

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Tirang R. Neyestani, Ph.D.

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tirang R. Neyestani, PhD

Role: STUDY_CHAIR

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

Other Identifiers

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054-574

Identifier Type: -

Identifier Source: org_study_id

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