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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: placebo; Dietary Supplement: fortified bread; Dietary Supplement: supplement

• Registration Number: NCT02516254
• Lead Sponsor: National Nutrition and Food Technology Institute

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.

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Study First Submitted: 2015-08-03
• Study First Submitted QC: 2015-08-04
• Study First Posted: 2015-08-05
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	daily intake of plain bread plus placebo
fortified bread	fortified bread	daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo
supplement	supplement	daily intake of plain bread (50 g) plus supplement (1000 IU per tablet)

Primary Outcome Measures

Name	Time	Method
25-hydroxyvitamin D (nmol/L)	8 weeks

Secondary Outcome Measures

Name	Time	Method
serum triglyceride (mg/dL)	8 weeks
serum glucose (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