Effect of supplementation in treatment of pregnancy complications

Effects of calcium and vitamin D co-supplementation on pre-elampsia parameters, metabolic status and biomarkers of oxidative stress in pregnant women at risk for pre-eclampsia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201102135444N3

Enrollment

Registered

2015-01-31

Start date

2014-09-06

Completion date

Unknown

Last updated

2021-06-21

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

Conditions

Pre-eclampsia. Sequelae of complication of pregnancy, childbirth and the puerperium

Interventions

Intervention 1: Intervention group: 50000 IU vitamin D pearl, each two weeks for 12 weeks + 1000 mg calcium tablet, daily for 12 weeks. Intervention 2: Control group: Vitamin D Placebo pearl, each tw

Eligibility

Sex/Gender

Female

Age

18 Years to 40 Years

Inclusion criteria

Inclusion criteria: Primigravida pregnant women Aged 18–40 years old At risk for pre-eclampsia Lived approximately 20 km or less from the clinic and hospital

Exclusion criteria

Exclusion criteria: Hypertension Renal diseases Gestational diabetes mellitus (GDM) Abnormal foetal anomaly scan

Design outcomes

Primary

Measure	Time frame
Pre-eclampsia rate. Timepoint: After delivery. Method of measurement: Medical record.;Low birth weight (LBW) (<2500 g). Timepoint: After delivery. Method of measurement: Scale.;Newborn's birth size. Timepoint: After delivery. Method of measurement: Scale and tape.;Preterm delivery (<37 weeks). Timepoint: After delivery. Method of measurement: Medical record.	—

Secondary

Measure	Time frame
Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.;Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;High-sensitivity C-reactive protein. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.;Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;HDL-cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Blood pressures. Timepoint: Baseline and End-of-trial. Method of measurement: Manometer.	—

Measure

Time frame

Insulin. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.;Nitric oxide. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;High-sensitivity C-reactive protein. Timepoint: Baseline and End-of-trial. Method of measurement: Eliza.;Total antioxidant capacity. Timepoint: Baseline and End-of-trial. Method of measurement: Spectrophotometry.;Fasting plasma glucose. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Triglyceride. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;HDL-cholesterol. Timepoint: Baseline and End-of-trial. Method of measurement: Enzymatic.;Blood pressures. Timepoint: Baseline and End-of-trial. Method of measurement: Manometer.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mansooreh Samimi

Kashan University of Medical Sciences

dr_samimi.2007@yahoo.com+98 31 5544 7619

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026