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

Healthy Clinical Trial

Official title:

Formulation of Vitamin D-fortified Sunflower Oil and Evaluation of the Efficacy of Its Consumption in Healthy Adults: a Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03826654
• Other study ID #: 24
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 1, 2018

Study information

• Verified date: January 2019
• Source: National Nutrition and Food Technology Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 1, 2018
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• fortified oil
35 g fortified sunflower oil
• Placebo
plain oil

Locations

Country	Name	City	State
Iran, Islamic Republic of	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

Sponsors (1)

Lead Sponsor	Collaborator
National Nutrition and Food Technology Institute

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	25-hydroxyvitamin D (nmol/L)		8 weeks
Secondary	serum glucose (mg/dL)		8 weeks
Secondary	serum triglyceride (mg/dL)		8 weeks
Secondary	serum total cholesterol (mg/dL)		8 weeks
Secondary	serum LDL		8 weeks
Secondary	serum HDL		8 weeks
Secondary	serum PTH (pg/mL)		8 weeks