NCT02516254

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 5, 2015

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

2 months

First QC Date

August 3, 2015

Last Update Submit

February 25, 2019

Conditions

Healthy

Keywords

vitamin Dfortified breadefficacyVitamin D Deficiency

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D (nmol/L)

    8 weeks

Secondary Outcomes (6)

  • serum glucose (mg/dL)

    8 weeks

  • serum triglyceride (mg/dL)

    8 weeks

  • serum total cholesterol (mg/dL)

    8 weeks

  • serum LDL

    8 weeks

  • serum HDL (mg/dL)

    8 weeks

  • +1 more secondary outcomes

Study Arms (3)

fortified bread

EXPERIMENTAL

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

Dietary Supplement: fortified bread

supplement

EXPERIMENTAL

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

Dietary Supplement: supplement

placebo

PLACEBO COMPARATOR

daily intake of plain bread plus placebo

Dietary Supplement: placebo

Interventions

fortified breadDIETARY_SUPPLEMENT

50 g of fortified bread + placebo daily

Also known as: FB
fortified bread
supplementDIETARY_SUPPLEMENT

vitamin D supplement+ plain bread

Also known as: SP
supplement
placeboDIETARY_SUPPLEMENT

plain bread+placebo

Also known as: PP
placebo

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 50 years
  • healthy subjects
  • no receiving vitamin D or omega-3 supplement in past 3 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Dietary Supplements

Condition Hierarchy (Ancestors)

AvitaminosisDeficiency DiseasesMalnutritionNutrition DisordersNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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 CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 5, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2015

Study Completion

April 1, 2015

Last Updated

February 27, 2019

Record last verified: 2019-02