The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital (HypoCal)

December 6, 2023 updated by: Tachjaree Panchalee, Siriraj Hospital
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

444

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Faculty of Medicine Siriraj Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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.
Experimental: 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.
Drug: Calcium supplement
Different amount of calcium supplement in pregnancy
Experimental: Hypocalcemia with receiving calcium supplement 1g/day
Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day.
Drug: Calcium supplement
Different amount of calcium supplement in pregnancy
Experimental: Hypocalcemia level with receiving calcium supplement 2g/day
Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day.
Drug: Calcium supplement
Different amount of calcium supplement in pregnancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of hypocalcemia in pregnant women at Siriraj Hospital
Time Frame: 1.5 year
The incidence of hypocalcemia in pregnant women in the first half of pregnancy. Material blood will be taken for calcium level. The hypocalcemia is defined as total calcium level less than 8.5 mg/dl.
1.5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The demographic and pregnant factors are associating with maternal calcium level in the first half of pregnancy assessed by the questionnaire and scrupulous chart review
Time Frame: 1.5 year
The different characteristics between normal calcium and hypocalcemia group in the first half of pregnancy will be studied. The data will be received by interviewing the patients, answering the questionnaire and scrupulous chart review; including age, education, occupations, income, marital status, food and nutrition status, previous pregnancy outcomes, family history, mode of conception in this pregnancy, gestational age of blood drawing, caffeine intake, smoking, and maternal hematocrit.
1.5 year
The calcium level in pregnant women in the third trimester
Time Frame: 2 year
Comparison of maternal serum calcium level in pregnant women in the third trimester between who receive and do not receive calcium supplement. In the normal calcium level group, pregnant women will be divided into 2 groups: receiving CaCO3 1 g/day and no receiving. In the hypocalcemia group, pregnant women will be divided into 2 groups: receiving CaCO3 1g/day and 2g/day. Maternal blood taking for serum calcium level will be done in all participants. Comparison of maternal calcium level between groups will be reported. Statistical analysis will be used t-test and p-value is less than 0.5.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Investigators

  • Study Director: Tachjaree Panchalee, MD, Faculty of Medicine Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2022

Primary Completion (Actual)

September 12, 2023

Study Completion (Estimated)

May 31, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

December 6, 2023

First Posted (Estimated)

December 7, 2023

Study Record Updates

Last Update Posted (Estimated)

December 7, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 1003/2021

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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