The effect of Vitamin D and calcium plus vitamin D for leg cramps in pregnant women

The effect of Vitamin D and calcium plus vitamin D for leg cramps in pregnant women: A randomised controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2013040810324N12

Enrollment

126

Registered

2013-05-04

Start date

2013-04-30

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Leg cramps in pregnant women. Pregnancy, childbirth and the puerperium

Interventions

Intervention 1: The first intervention group will receive1000 units vitamin D daily for 60 days. Intervention 2: The second intervention group will receive 300 mg carbonate calcium plus 1000 units v

Treatment - Drugs

Placebo

The first intervention group will receive1000 units vitamin D daily for 60 days.

The second intervention group will receive 300 mg carbonate calcium plus 1000 units vitamin D daily for 60 days.

The control group will receive 500 mg placebo tablet daily for 60 days. Placebo tablets contain avisel, lactose and starch.

Eligibility

Sex/Gender

Female

Age

18 Years to 35 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Pregnant women with gestational age of 25-30 weeks aged 18 to 35 years old; having Leg cramps at least twice a week; being literate. Exclusion criteria: Having known thyroid, cardio-vascular, diabetes or renal diseases; intake of calcium and vitamin D supplementation during pregnancy; having allergy history to studied drugs.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
The number of leg cramps. Timepoint: Before interventions, 4 and 8 weeks after intervention. Method of measurement: Daily counts.;Severity of leg cramps. Timepoint: Before interventions, 4 and 8 weeks after intervention. Method of measurement: Visual Analog Scale (VAS).;Duration of leg cramps. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: According to minute.	—

Measure

Time frame

The number of leg cramps. Timepoint: Before interventions, 4 and 8 weeks after intervention. Method of measurement: Daily counts.;Severity of leg cramps. Timepoint: Before interventions, 4 and 8 weeks after intervention. Method of measurement: Visual Analog Scale (VAS).;Duration of leg cramps. Timepoint: Before intervention, 4 and 8 weeks after intervention. Method of measurement: According to minute.

—

Secondary

Measure	Time frame
Sleep quality scores. Timepoint: Before and after intervention. Method of measurement: Pittsburgh Sleep Quality Index.;Anthropometric indices. Timepoint: After delivery. Method of measurement: Newborn growth monitoring form.;Preterm labor. Timepoint: after delivery. Method of measurement: Frequency.;Cesarean delivery. Timepoint: After delivery. Method of measurement: Frequency.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMansouri Ameneh

Faculty of Nursing & Midwifery, Tabriz University of Medical Sciences

amene_mansouri66@yahoo.com+98 26 3456 3396

Outcome results

None listed

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