Effect of supplementation in treatment of pregnant women at risk for intrauterine growth restriction

Clinical trial of the effect of selenium supplementation compared with the placebo on metabolic profiles in pregnant women at risk for intrauterine growth restriction

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201601045623N64

Enrollment

Registered

2016-01-31

Start date

2015-12-23

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

Pregnancy. Sequelae of complication of pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: Selenium supplement (Nature Made, California, USA, 100 µg, daily, for 10 weeks orally. Intervention 2: Control group: Placebo (Barij Essence, Kashan, Iran), daily,

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Pregnant women at risk for intrauterine growth restriction Aged 18 to 40 years

Exclusion criteria

Exclusion criteria: Taking selenium supplements during past 3 months Hypo- and hyperthyroidism Urinary tract infection Pre-eclampsia Hypertension Diseases related to increased inflammation Smokers Kidney or liver diseases

Design outcomes

Primary

Measure	Time frame
Total antioxidant. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Pulsatility index. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Sonography.	—

Measure

Time frame

Total antioxidant. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Pulsatility index. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Sonography.

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Secondary

Measure	Time frame
Insulin. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Cholesterol. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;HDL. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Insulin. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit.;Nitric oxide. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;Hs-CRP. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Elisa kit.;Triglycerides. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Cholesterol. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Malondialdehyde. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Spectrophotometry.;HDL. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 10 weeks of intervention. Method of measurement: Enzymatic kit.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactZatollah Asemi

Kashan University of Medical Sciences

asemi_z@kaums.ac.ir+98 31 5562 0608

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Mar 11, 2026