NCT03826654

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

Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption 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 – 60 Years
• Healthy volunteers: Accepted

Summary

The aim of this study is to evaluate the efficacy of daily intake of fortified sunflower oil with vitamin D on serum 25-hydroxyvitamin D level, glycemic and lipidemic status in healthy subjects compared to plain oil.

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 two intervention groups: 1.fortified sunflower oil, 2. plain bread+vitamin D supplements,3. plain bread+placebo. Each participant will consume 50 g of oil every day for 2 months. At the first and last visits, dietary and laboratory assessments will be performed for all subjects. Primary outcomes are the improvement in vitamin D status and secondary outcome is the improvement of glycemic and lipidemic markers and prevention of problems related to hypovitaminosis D.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	fortified oil	35 g fortified sunflower oil
DIETARY_SUPPLEMENT	Placebo	plain oil

Timeline

• Start date: 2018-01-01
• Primary completion: 2018-04-01
• Completion: 2018-07-01
• First posted: 2019-02-01
• Last updated: 2019-02-01

Locations

1 site across 1 country: Iran