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The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital

NCT ID: NCT06160479

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

444 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-05

Study Completion Date

2024-05-31

Brief Summary

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Calcium is an essential element for fundamental physiological functions and during pregnancy. However, higher calcium intake can induce constipation, flatulence, nausea, or kidney stones. This study aims to evaluate the incidence of hypocalcemia among pregnant women in the first half of pregnancy in Thailand. Also, Comparison of calcium level in pregnant women in the third trimester who received and not received calcium during pregnancy.

Detailed Description

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The primary outcome is the incidence of hypocalcemia among pregnant women in the first half of pregnancy. This study also has secondary objectives. The one is associating factors with calcium level. After getting the results of maternal calcium level, the normal calcium level group will be divided into 2 groups for receiving calcium 1 g/day and no receiving calcium supplement. Another with hypocalcemia group will be decided into 2 groups for receiving calcium 1 g/day and 2 g/day. The calcium level was collected again in the third trimester.

Conditions

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Hypocalcemia in Pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Normal calcium level with no receiving calcium supplement

Pregnant women with normal calcium level in the first half of pregnancy do not receive calcium supplement.

Group Type NO_INTERVENTION

No interventions assigned to this group

Normal calcium level with receiving calcium supplement 1g/day

Pregnant women with normal calcium level in the first half of pregnancy receive calcium supplement 1g/day.

Group Type EXPERIMENTAL

Calcium supplement

Intervention Type DRUG

Different amount of calcium supplement in pregnancy

Hypocalcemia with receiving calcium supplement 1g/day

Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day.

Group Type EXPERIMENTAL

Calcium supplement

Intervention Type DRUG

Different amount of calcium supplement in pregnancy

Hypocalcemia level with receiving calcium supplement 2g/day

Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day.

Group Type EXPERIMENTAL

Calcium supplement

Intervention Type DRUG

Different amount of calcium supplement in pregnancy

Interventions

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Calcium supplement

Different amount of calcium supplement in pregnancy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant women who attend antenatal care clinic in Siriraj Hospital
* Pregnant women with gestation less than 20 weeks of gestation
* Singleton pregnancy

Exclusion Criteria

* Pregnant women who has underlying diseases including liver disease and vitamin D deficiency
* Pregnant women are malnutrition patients
* Pregnant women who receive calcium supplement before enrollment
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Siriraj Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tachjaree Panchalee

Assistant Professor Tachjaree Panchalee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tachjaree Panchalee, MD

Role: STUDY_DIRECTOR

Siriraj Hospital

Locations

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Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si 1003/2021

Identifier Type: -

Identifier Source: org_study_id