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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20100130003226N17
Enrollment
168
Registered
2019-02-09
Start date
2019-02-04
Completion date
Unknown
Last updated
2019-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 fo

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
15 Years to 50 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahrokh Dolatian

Shahid Beheshti University of Medical Sciences

m_dolatian@sbmu.ac.ir+98 218865536671

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 27, 2026