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

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Placebo; Dietary Supplement: fortified oil

• Registration Number: NCT03826654
• Lead Sponsor: National Nutrition and Food Technology Institute

Brief 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.

Study Timeline

• Study Start: 2018-01-01
• Primary Completion: 2018-04-01
• Study Completion: 2018-07-01
• Status Verified: 2019-01
• Study First Submitted: 2019-01-31
• Study First Submitted QC: 2019-01-31
• Last Update Submitted: 2019-01-31
• Study First Posted: 2019-02-01
• Last Update Posted: 2019-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 20 to 60 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Placebo	daily intake of plain oil
fortified oil	fortified oil	daily intake of fortified sunflower oil (700IU vitamin D/ 35g)

Primary Outcome Measures

Name	Time	Method
25-hydroxyvitamin D (nmol/L)	8 weeks

Secondary Outcome Measures

Name	Time	Method
serum LDL	8 weeks
serum HDL	8 weeks
serum triglyceride (mg/dL)	8 weeks
serum PTH (pg/mL)	8 weeks
serum glucose (mg/dL)	8 weeks
serum total cholesterol (mg/dL)	8 weeks

Trial Locations

Locations (1)

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; 🇮🇷 Tehran, Iran, Islamic Republic of