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

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: Healthy
• Intervention / Treatment: Dietary supplement: fortified bread; Dietary supplement: supplement; Dietary supplement: placebo

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

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

How is the study designed?

Design Details

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

Number of Arms

3

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)	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• 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

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: efficacy; vitamin D; Vitamin D Deficiency; fortified bread
• Other Study ID Numbers: 054-574