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Completed

NCT Number: NCT03826654

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

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.

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Key information

Conditions

Healthy

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

fortified oil

Dietary Supplement

35 g fortified sunflower oil

Placebo

Dietary Supplement

plain oil

Primary outcomes

  1. 25-hydroxyvitamin D (nmol/L)

    Time frame: 8 weeks

Secondary outcomes

  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

    Time frame: 8 weeks

  6. serum PTH (pg/mL)

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2019
Registry last updated
Feb 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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