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

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ClinicalTrials.gov Identifier: NCT02516254
Recruitment Status : Completed
First Posted : August 5, 2015
Last Update Posted : February 27, 2019
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: fortified bread Dietary Supplement: supplement Dietary Supplement: placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: Comparison of the Efficacy of Vitamin D-fortified Bread Versus Vitamin D Supplement in Healthy Adults: a Randomized Controlled Clinical Trial
Study Start Date : January 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Vitamin D

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 Name: 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 Name: SP

Placebo Comparator: placebo
daily intake of plain bread plus placebo
Dietary Supplement: placebo
plain bread+placebo
Other Name: PP




Primary Outcome Measures :
  1. 25-hydroxyvitamin D (nmol/L) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. serum glucose (mg/dL) [ Time Frame: 8 weeks ]
  2. serum triglyceride (mg/dL) [ Time Frame: 8 weeks ]
  3. serum total cholesterol (mg/dL) [ Time Frame: 8 weeks ]
  4. serum LDL [ Time Frame: 8 weeks ]
  5. serum HDL (mg/dL) [ Time Frame: 8 weeks ]
  6. serum PTH (pg/mL) [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02516254


Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
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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
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Responsible Party: Tirang R. Neyestani, Ph.D., Professor, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02516254    
Other Study ID Numbers: 054-574
First Posted: August 5, 2015    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
Keywords provided by Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute:
vitamin D
fortified bread
efficacy
Vitamin D Deficiency