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

National Nutrition and Food Technology Institute

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: placebo; Dietary Supplement: fortified bread; Dietary Supplement: supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT02516254

054-574

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups, including a placebo group

fortified bread

Experimental group

Description:

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

Treatment:

Dietary Supplement: fortified bread

supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: supplement

placebo

Placebo Comparator group

Description:

daily intake of plain bread plus placebo

Treatment:

Dietary Supplement: placebo