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

Study Overview
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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.

Official Title
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Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: fortified bread
* Dietary Supplement: supplement
* Dietary Supplement: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fortified bread<br>daily intake of fortified bread (1000IU vitamin D per 50 g) plus placebo | Dietary Supplement: fortified bread<br>* 50 g of fortified bread + placebo daily<br>* Other names: FB;|
| Experimental: supplement<br>daily intake of plain bread (50 g) plus supplement (1000 IU per tablet) | Dietary Supplement: supplement<br>* vitamin D supplement+ plain bread<br>* Other names: SP;|
| Placebo Comparator: placebo<br>daily intake of plain bread plus placebo | Dietary Supplement: placebo<br>* plain bread+placebo<br>* Other names: PP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25-hydroxyvitamin D (nmol/L) |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 HDL (mg/dL) |  | 8 weeks | 
| serum PTH (pg/mL) |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitamin D, fortified bread, efficacy, Vitamin D Deficiency