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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826654
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
Tirang R. Neyestani, Ph.D., 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.

Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: fortified oil Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : April 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vitamin D
Drug Information available for: Vitamin D

Arm Intervention/treatment
Experimental: fortified oil
daily intake of fortified sunflower oil (700IU vitamin D/ 35g)
Dietary Supplement: fortified oil
35 g fortified sunflower oil

Placebo Comparator: control
daily intake of plain oil
Dietary Supplement: Placebo
plain oil




Primary Outcome Measures :
  1. 25-hydroxyvitamin D (nmol/L) [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826654


Locations
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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, Iran, Islamic Republic of
Sponsors and Collaborators
National Nutrition and Food Technology Institute
Investigators
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Study Chair: Tirang R. Neyestani, PhD 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tirang R. Neyestani, Ph.D., Prof., National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT03826654    
Other Study ID Numbers: 24
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tirang R. Neyestani, Ph.D., National Nutrition and Food Technology Institute:
vitamin D
fortified oil