]>
IRCT20100130003226N17 IRCT 2019-02-09 Shahid Beheshti University of Medical Sciences Effect of omega-3 and vitamin D on women with pre- diabetes and hypo vitaminosis D 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 2019-02-04 anticipated 168 Complete https://irct.ir/trial/35689 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Factorial, Purpose: Prevention, 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 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. 3 Condition 1: prediabetes. Condition 2: Vitamin D deficiency. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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). Intervention 4: Control group:4 Vitamin D placebo+ omega-3 placebo for 8 weeks.0mega3 and Vitamin D placebo is produced by Zahravi Pharmaceutical Company. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Mahrokh Dolatian
Valiasr Str., intersection of Niyayesh
Tehran Iran (Islamic Republic of) 1985717443 +98 218865536671 m_dolatian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Dolatian Mahrokh
Valiasr Str., intersection of Niyayesh
Tehran Iran (Islamic Republic of) 1985717443 +98 218865536671 m_dolatian@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Reproductive-aged women (age15-50 years) FBS 100-125 mg/ml serum vitamin D level < 32 ng/mL BMI < 30 15 years 50 years Female 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 R73.0 E55.9 Abnormal glucose tolerance test Vitamin D deficiency, unspecified Prevention Prevention Prevention Prevention 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 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 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). Control group:4 Vitamin D placebo+ omega-3 placebo for 8 weeks.0mega3 and Vitamin D placebo is produced by Zahravi Pharmaceutical Company 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). 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. 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). Score of Pittsburgh Sleep Quality Index (PSQI). Timepoint: at beginning and after 8 weeks intervention. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Weight. Timepoint: At beginning and after 8 weeks intervention. Method of measurement: Digital scale. 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). Systolic and diastolic blood pressure. Timepoint: At beginning and after 8 weeks intervention. Method of measurement: Digital manometer. Waist circumference. Timepoint: At beginning and after 8 weeks intervention. Method of measurement: Nonelastic tape. Shahid Beheshti University of Medical Sciences Approved 2018-11-04 Ethics committee of Shahid Beheshti University of Medical Sciences 6th Floor, Bldg No.2 SBUMS,Parvaneh Str., Yemeni Ave, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)