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Comparative study on the effectiveness of omega-3, vitamin D and co-supplementation on glycemic status, serum lipids and psycological distress in reproductive-aged women with pre- diabetes and hypovitaminosis D

Protocol summary

Study aim
Determination and comparison of the effect of omega-3, vitamin D and co-supplementation on glycemic status, serum lipids and psycological distress in reproductive-aged women with pre - diabetes and hypovitminosis D
Design
A factorial Clinical trial with control group , triple-blinded and randomized phase 3 of the trial
Settings and conduct
This study will be conducted at Shahid Rastravesh Health Center Laboratory in Karaj. 15-50 years old women with with pre - diabetes and hypovitminosis D if they have inclution criteria, are randomized into 4 groups according to the Stratified Block Randomization. At baseline and after 8 weeks intervention , physical activity, DASS-21 and PSQI and a 3-day food record will be collected for each subject. Also blood pressure, weight, height and waist circumference will be measured. At the beginning and at the end, a blood sample is used for estimating serum glucose indices , lipids and vitamin D. Finally, in168 samples according to the appropriate statistical tests, the results of the comparison of efficacy of two these supplements are investigated. ________________________________________
Participants/Inclusion and exclusion criteria
Women aged 15-50; FBS: 100-125 mg/ml; Vitamin D < 32 ng/mL; BMI < 30 ; Not intake of drugs that interfere with vitamin D oromega-3; Not Pregnancy; Not lactation; Absence of diagnosed systemic diseases
Intervention groups
The first group (omega-3 and vitamin D placebo), the second group (Omega-3 placebo and vitamin D supplement), the third group (omega-3 supplement and vitamin D placebo), and the fourth group (supplement of omega-3 and vitamin D)
Main outcome variables
glycemic status (FBS, insulin, HOMA- IR, HOMA- B), lipid profile (triglyceride, total cholesterol, HDL cholesterol, LDL-cholesterol) and psychological distress (depression, anxiety, stress and quality of sleep)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100130003226N17
Registration date: 2019-02-09, 1397/11/20
Registration timing: registered_while_recruiting

Last update: 2019-02-09, 1397/11/20
Update count: 0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Mahrokh Dolatian
Name of organization / entity
Shahid Beheshti University of Medical Scenices
Country
Iran (Islamic Republic of)
Phone
+98 21 8820 2512
Email address
m_dolatian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-04, 1397/11/15
Expected recruitment end date
2019-09-23, 1398/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study on the effectiveness of omega-3, vitamin D and co-supplementation on glycemic status, serum lipids and psycological distress in reproductive-aged women with pre- diabetes and hypovitaminosis D
Public title
Effect of omega-3 and vitamin D on women with pre- diabetes and hypo vitaminosis D
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Reproductive-aged women (age15-50 years) FBS 100-125 mg/ml serum vitamin D level < 32 ng/mL BMI < 30
Exclusion criteria:
Diagnosed pathological conditions such as thyroid or para thyroid disorders, PCO, seizures, liver or kidney disease, neurological disorders, cancer, cardiovascular disease, type 1 or 2 diabetes, Sarcoidosis or other Granulomatous disorder Intakes vitamin D or omega-3 during the last 6 months Breast feeding, pregnant, and/or planning for pregnancy in the following 2 months Intake of drugs that interact with omega-3 [including aspirin or anticoagulants (warfarin, heparin)] or with vitamin D (such as cardiac glycosides, Cholestyramine, anticonvulsant drugs or thiazides) Taking herbal or chemical drugs that affect serum lipids or blood glucose level In case of taking prescribed supplements different from study protocol Unwillingness to provide blood sample during the initial or final visits or not to continue participating in research
Age
From 15 years old to 50 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 168
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method:Eligible participants are randomized into treatments with either double placebo, vitamin D alone, omega-3 alone or double active (vitamin D and omega-3) groups according to the Stratified Block Randomization. Random unit: Block randomization is done in equal block sizes of 4 to ensure the balance between groups. Stratified randomization will be used to control serum vitamin D level (Vitamin D<20 ng/ml, Vitamin D: 20~32 ng/ml) distribution. Randomization Tool: Statistical software Randomization is carried out by an individual who is not involved in trial data collection and analysis. Allocation concealment:The intervention allocation will be blinded to the study investigators, participants and statistical analyzer.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Vitamin D and omega-3 supplements and placeboes were produced by Zahravi Pharmaceutical Company (Tabriz, Iran).The appearance of the placebo capsule was indistinguishable in color, shape, size, packaging, smell and taste from vitamin D and omega-3 capsules. Packaging and Labeling of drugs for each group is done by an individual who is not involved in trial data collection and analysis The type of supplements in each group is blinded as A, B, C and D packages for investigators, participants and statistical analyzer.
Placebo
Used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
6th Floor, Bldg No.2 SBUMS,Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2018-11-04, 1397/08/13
Ethics committee reference number
IR.SBMU.RETECH.REC.1397.615

Health conditions studied

1

Description of health condition studied
prediabetes
ICD-10 code
R73.0
ICD-10 code description
Abnormal glucose tolerance test

2

Description of health condition studied
Vitamin D deficiency
ICD-10 code
E55.9
ICD-10 code description
Vitamin D deficiency, unspecified

Primary outcomes

1

Description
glycemic status[fasting blood sugar and insulin, homeostasis model assessment-insulin resistance (HOMA-IR), homeostasis model assessment-beta cell function (HOMA-B)]
Timepoint
at beginning and after 8 weeks intervention
Method of measurement
Blood sampling and calculating (HOMA-IR) and (HOMA-B)

2

Description
serum lipids (triglyceride, low-density lipoprotein-cholesterol, high-density lipoprotein-cholesterol, total cholesterol)
Timepoint
at beginning and after 8 weeks intervention
Method of measurement
Blood sampling

3

Description
scores of Depression Anxiety Stress Scale (DASS 21)
Timepoint
at beginning and after 8 weeks intervention
Method of measurement
Depression Anxiety Stress Scale (DASS 21)

4

Description
Score of Pittsburgh Sleep Quality Index (PSQI)
Timepoint
at beginning and after 8 weeks intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

1

Description
weight
Timepoint
At beginning and after 8 weeks intervention
Method of measurement
Digital scale

2

Description
Body mass index (BMI)
Timepoint
At beginning and after 8 weeks intervention
Method of measurement
It will be calculated using the height and weight measurements w/h2 (w: weight in kg and h: height in meters).

3

Description
Systolic and diastolic blood pressure
Timepoint
At beginning and after 8 weeks intervention
Method of measurement
Digital manometer

4

Description
Waist circumference
Timepoint
At beginning and after 8 weeks intervention
Method of measurement
Nonelastic tape

Intervention groups

1

Description
Intervention group1: 1000 mg omega-3 [each capsule containing 180 mg eicosapentaenoic acid (EPA) and 120 mg docosahexaenoic acid (DHA)] twice a day + vitamin D placebo every 2 weeks for 8 weeks. 0mega3 supplement is produced by Zahravi Pharmaceutical Company (IRC: 1228058530 / GTIN: 06260155920675). Vitamin D placebo is produced by Zahravi Pharmaceutical Company
Category
Prevention

2

Description
Intervention group2: Capsule vitamin D (50,000 IU ) every 2 weeks + omega-3 placebo twice a day for 8 weeks.Vitamin D supplement is produced by Zahravi Pharmaceutical Company (IRC: 1228055799/ GTIN: 06260155960213). 0mega3 placebo is produced by Zahravi Pharmaceutical Company
Category
Prevention

3

Description
Intervention group3: 1000 mg omega-3 [each capsule containing 180 mg eicosapentaenoic acid (EPA) and 120 mg docosahexaenoic acid (DHA)] twice a day + Capsule vitamin D (50,000 IU ) every 2 weeks.0mega3 supplement is produced by Zahravi Pharmaceutical Company (IRC: 1228058530 / GTIN: 06260155920675).Vitamin D supplement is produced by Zahravi Pharmaceutical Company (IRC: 1228055799/ GTIN: 06260155960213).
Category
Prevention

4

Description
Control group:4 Vitamin D placebo+ omega-3 placebo for 8 weeks.0mega3 and Vitamin D placebo is produced by Zahravi Pharmaceutical Company
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
آزمایشگاه مرکز بهداشت شهید راست روش
Full name of responsible person
معصومه رجبی نائینی
Street address
Vahdat st.South Taleghani blvd
City
Karaj
Province
Alborz
Postal code
3133968111
Phone
+98 26 3270 0011
Fax
+98 26 3270 0011
Email
alborzuniverlab@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
University Building No. 2 of ShahidBeheshti University of Medical Sciences, Parvaneh Str., Yemeni Ave, Shahid Chamran Highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9781
Fax
+98 21 2243 9981
Email
zarghi@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahrokh Dolatian
Position
Vice-Chancellor of Research, Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Str., intersection of Niyayesh
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2521
Email
m_dolatian@sbmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dolatian Mahrokh
Position
Vice-Chancellor of Research, Faculty of Nursing and Midwifery
Latest degree
Ph.D.
Other areas of specialty/work
Midwifery
Street address
Valiasr Str., intersection of Niyayesh
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 218865536671
Fax
+98 21 8820 2512
Email
m_dolatian@sbmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoumeh Rajabi Naeeni
Position
PhD student reproductive health
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Vali-Asr Avenue, Cross of Vali-Asr and Neiaiesh Highway.School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1996835119
Phone
+98 21 8820 2512
Fax
+98 21 8820 2512
Email
rajabishirin@ymail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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