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

National Nutrition and Food Technology Institute

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Placebo; Dietary Supplement: fortified oil

Study type: Interventional

Funder types: Other

Identifiers

NCT03826654

24

Details and patient eligibility

About

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.

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 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.

Enrollment: 60 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

fortified oil

Experimental group

Description:

daily intake of fortified sunflower oil (700IU vitamin D/ 35g)

Treatment:

Dietary Supplement: fortified oil

control

Placebo Comparator group

Description:

daily intake of plain oil

Treatment:

Dietary Supplement: Placebo