NCT03826654

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2019

Completed
Last Updated

February 1, 2019

Status Verified

January 1, 2019

Enrollment Period

3 months

First QC Date

January 31, 2019

Last Update Submit

January 31, 2019

Conditions

Healthy

Keywords

vitamin Dfortified oil

Outcome Measures

Primary Outcomes (1)

  • 25-hydroxyvitamin D (nmol/L)

    8 weeks

Secondary Outcomes (6)

  • serum glucose (mg/dL)

    8 weeks

  • serum triglyceride (mg/dL)

    8 weeks

  • serum total cholesterol (mg/dL)

    8 weeks

  • serum LDL

    8 weeks

  • serum HDL

    8 weeks

  • +1 more secondary outcomes

Study Arms (2)

fortified oil

EXPERIMENTAL

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

Dietary Supplement: fortified oil

control

PLACEBO COMPARATOR

daily intake of plain oil

Dietary Supplement: Placebo

Interventions

fortified oilDIETARY_SUPPLEMENT

35 g fortified sunflower oil

fortified oil
PlaceboDIETARY_SUPPLEMENT

plain oil

control

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • to 60 years
  • healthy subjects
  • no receiving vitamin D or omega-3 supplement in past 3 months

You may not qualify if:

  • \- receiving vitamin D or omega-3 supplement during the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (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

Location

Related Publications (1)

  • Nikooyeh B, Zargaraan A, Kalayi A, Shariatzadeh N, Zahedirad M, Jamali A, Khazraie M, Hollis B, Neyestani TR. Vitamin D-fortified cooking oil is an effective way to improve vitamin D status: an institutional efficacy trial. Eur J Nutr. 2020 Sep;59(6):2547-2555. doi: 10.1007/s00394-019-02103-4. Epub 2019 Oct 12.

    PMID: 31606753DERIVED

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 31, 2019

First Posted

February 1, 2019

Study Start

January 1, 2018

Primary Completion

April 1, 2018

Study Completion

July 1, 2018

Last Updated

February 1, 2019

Record last verified: 2019-01

Locations

IR(1)