NCT02516254

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: National Nutrition and Food Technology Institute · Academic / Other
• Sex: All
• Age: 20 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fortified bread	50 g of fortified bread + placebo daily
DIETARY_SUPPLEMENT	supplement	vitamin D supplement+ plain bread
DIETARY_SUPPLEMENT	placebo	plain bread+placebo

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2015-08-05
• Last updated: 2019-02-27