Effect of omega-3 and vitamin D on women with pre- diabetes and hypo vitaminosis D

Phase 3

Recruiting

Conditions: Condition 1: prediabetes. Condition 2: Vitamin D deficiency.
Abnormal glucose tolerance test
Vitamin D deficiency, unspecified

Registration Number: IRCT20100130003226N17

Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Female

Target Recruitment: 168

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.