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Comparison of the effects of vitamin D fortified oil and vitamin D supplement in improving vitamin D status and bone turnover factors among 18-30 healthy persons.

Protocol summary

Study aim
Comparing the effect of vitamin D supplement and vitamin D enriched oil on serum vitamin D status and bone turnover indices in healthy individuals aged 18 to 30 years
Design
Clinical trial with three parallel intervention groups including 33 participants. Double-blinded, randomized using random digits table
Settings and conduct
Following inviting people to the study, eligible volunteers will be entered the study. Participants will be grouped in A, B and C groups. The study will be double blinded. After the initial blood sampling, participants will use pills and oil for 3 months. At the end of the third month, blood sampling will be done again and 25(OH)D, PTH, BAP and CTX-I will be measured and compared with parameters of the final and first blood samples.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 30-18 years old Exclusion criteria: Diseases which influence the metabolism of P, Ca and vitamin D Treatment for osteoporosis in the last 6 months Using Glucocorticoids Pregnancy or lactating Participating in other studies in the last 6 months
Intervention groups
Group 1: A supplement tablet containing 1000 IU of vitamin D per day + 25 g of ordinary canola oil, group 2: a placebo tablet + 25 grams of vitamin D enriched canola oil containing 1000 IU of vitamin D per day; group 3: a placebo tablet + 25 grams of ordinary canola oil per day
Main outcome variables
25-hydroxy vitamin D, PTH, bone specific alkalin phosphatase (BAP), CTX-I

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180708040401N1
Registration date: 2018-10-04, 1397/07/12
Registration timing: registered_while_recruiting

Last update: 2018-10-04, 1397/07/12
Update count: 0
Registration date
2018-10-04, 1397/07/12
Registrant information
Name
Negar Ghasemifard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3725 1006
Email address
nghasemifard@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of vitamin D fortified oil and vitamin D supplement in improving vitamin D status and bone turnover factors among 18-30 healthy persons.
Public title
Fortification and supplementation effect on vitamin D levels
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18-30 years old The absence of diseases which influence the metabolism of Ca, P and vitamin D such as thyroid and parathyroid disorders, chronic kidney disease, osteoporosis, or bone fractures caused by osteoporosis, during the past year The absence of cardiovascular disease, diabetes, chronic digestive diseases, hepatitis and cancer No medical treatment for osteoporosis or other bone diseases in the last 6 months, such as taking Bisphosphonates, Raloxifene, Teriparatide and Denosambe Not using Glucocorticoids Not using nutritional supplements No pregnancy and lactation Not participating in other studies in the last 6 months
Exclusion criteria:
The presence of diseases affecting the metabolism of phosphorus, calcium and vitamin D The presence of cardiovascular disease, diabetes, chronic diseases of the digestive tract, hepatitis and cancer Medical treatment for osteoporosis or other bone diseases in the last 6 months Treatment with glucocorticoids Using nutritional supplements Pregnancy and lactating Participating in other studies in the last 6 months
Age
From 18 years old to 30 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 99
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization by random digits table: participants are numbered from 1 to 99, then a row and a column of the random digits table are chosen randomly, the place of intersection of the row and the column is considered as the beginning point. We move our hand continuously on the table, the first number which the last two digits are the number of one of participants, is placed in the first group, the second number in the second group, the third number in the third group; and we go on to dedicate 33 participants in each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Someone who is not participating in the study, grouped oils and pills, then delivered them to the researcher so all individuals involved in the study are blind. Placebo pills are quite similar to vitamin D pills (produced by the same company). Fortified oil are also completely the same as unfortified oil in terms of color and packaging.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Science
Street address
Central Building of Shiraz University of Medical Sciences-opposite Palestin Street-Zand Avenue
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2017-11-05, 1396/08/14
Ethics committee reference number
IR.SUMS.REC.1396.124

Health conditions studied

1

Description of health condition studied
Healthy people
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
25-hydroxy vitamin D
Timepoint
Beginning of the study (before starting intervention), at the end of the study (after the end of intervention)
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)

2

Description
Parathyroid hormone
Timepoint
Beginning of the study (before starting intervention), at the end of the study (after the end of intervention)
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)

3

Description
Bone specific alkalin phosphatase
Timepoint
Beginning of the study (before starting intervention), at the end of the study (after the end of intervention)
Method of measurement
Spectophotometric assay

4

Description
collagen type 1 cross-linked C-telopeptide I(CTX-I)
Timepoint
Beginning of the study (before starting intervention), at the end of the study (after the end of intervention)
Method of measurement
Enzyme-linked immunosorbent assay (ELISA)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: a supplement tablet containing 1000 IU vitamin D per day + 25 gram ordinary canola oil
Category
Treatment - Drugs

2

Description
Intervention group: a placebo tablet + 25 gram canola oil enriched by 1000 IU vitamin D per day
Category
Treatment - Drugs

3

Description
Control group: a placebo tablet + 25 gram ordinary canola oil
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam Reza clinic
Full name of responsible person
Ali Jangjo
Street address
Emam Reza specialized clinic, next to blood transfusion center, Namazi square
City
Shiraz
Province
Fars
Postal code
71348714737
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Research and Technology Deputy of Shiraz University of Medical Sciences
Street address
Research and technology deputy-7 floor-central building of Shiraz university of medical science-opposite Palestin Street-Zand Avenue
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Grant name
Research grant
Grant code / Reference number
SG-96-14
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiva Faghih
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and food science faculty, opposite of Bargh club, Razi Blvd
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Fax
+98 71 3725 7288
Email
Sh_faghih@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shiva Faghih
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition and food science faculty, opposite of Bargh club, Razi Blvd
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Fax
+98 71 3725 7288
Email
Sh_faghih@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Negar Ghasemifard
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Nutrition and food science faculty, opposite of Bargh club, Razi Blvd
City
Shiraz
Province
Fars
Postal code
71536-75541
Phone
+98 71 3725 1001
Fax
+98 71 3725 7288
Email
nghasemifard@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data file, information related to main variable will be shared. The study protocol is fully be shared. I will share the informed consent forms.
When the data will become available and for how long
first accessibility after submitting the article.
To whom data/document is available
Data will be available to academic researchers.
Under which criteria data/document could be used
I have not decided yet.
From where data/document is obtainable
Doctor Shiva Faghih: shivafaghih@gamail.com
What processes are involved for a request to access data/document
After posting the email, his request is checked and, if the criteria are met, the data will be sent to him.
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