Hypocalcemia in PregnancyHypoCalNCT06160479
The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital
A study testing Calcium supplement in people with Hypocalcemia in Pregnancy, run by Siriraj Hospital at 1 site in Thailand.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypocalcemia in Pregnancy
- What is being tested?
- Calcium supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 444 participants
- Where
- 1 siteThailand
- Study dates
- 5 May 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women who attend antenatal care clinic in Siriraj Hospital
- Pregnant women with gestation less than 20 weeks of gestation
- Singleton pregnancy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700
About this study
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.
Read the 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.
- Conditions
- Hypocalcemia in Pregnancy
- Being tested
- Calcium supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium supplementDrug
Different amount of calcium supplement in pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Normal calcium level with no receiving calcium supplement | No intervention | Pregnant women with normal calcium level in the first half of pregnancy do not receive calcium supplement. |
| Normal calcium level with receiving calcium supplement 1g/day | Experimental | Pregnant women with normal calcium level in the first half of pregnancy receive calcium supplement 1g/day. Receives: Drug: Calcium supplement |
| Hypocalcemia with receiving calcium supplement 1g/day | Experimental | Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day. Receives: Drug: Calcium supplement |
| Hypocalcemia level with receiving calcium supplement 2g/day | Experimental | Pregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day. Receives: Drug: Calcium supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of hypocalcemia in pregnant women at Siriraj Hospital
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.
Measured: 1.5 year
Secondary outcomes (2)
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
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.
Measured: 1.5 year
The calcium level in pregnant women in the third trimester
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.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start5 May 2022
- Primary completion12 Sep 2023
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypocalcemia in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 444 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Siriraj Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tachjaree Panchalee, Siriraj Hospital
- Investigators
- Tachjaree Panchalee, MD, Study director, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160479
- Sponsor's protocol ID
- Si 1003/2021
- Acronym
- HypoCal
- Status last verified
- Dec 2023
- First submitted
- 27 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence of Hypocalcemia in Pregnant Women at Siriraj Hospital
- ClinicalTrials.gov ID
- NCT06160479
- Acronym / sponsor ID
- HypoCal / Si 1003/2021
- Conditions
- Hypocalcemia in Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 444 participants (estimated)
- Lead sponsor
- Siriraj HospitalUniversity, hospital or other
- Study start
- 5 May 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal calcium level with no receiving calcium supplement | No intervention | –Pregnant women with normal calcium level in the first half of pregnancy do not receive calcium supplement. |
| Normal calcium level with receiving calcium supplement 1g/day | Experimental | Drug: Calcium supplementPregnant women with normal calcium level in the first half of pregnancy receive calcium supplement 1g/day. |
| Hypocalcemia with receiving calcium supplement 1g/day | Experimental | Drug: Calcium supplementPregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 1g/day. |
| Hypocalcemia level with receiving calcium supplement 2g/day | Experimental | Drug: Calcium supplementPregnant women with hypocalcemia in the first half of pregnancy receive calcium supplement 2g/day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Pregnant women who attend antenatal care clinic in Siriraj Hospital
- Pregnant women with gestation less than 20 weeks of gestation
- Singleton pregnancy
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium supplementDifferent amount of calcium supplement in pregnancy | Drug | Hypocalcemia level with receiving calcium supplement 2g/day, Hypocalcemia with receiving calcium supplement 1g/day, Normal calcium level with receiving calcium supplement 1g/day |
Primary outcome
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.
2 secondary outcomes
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 calcium level in pregnant women in the third trimester
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Related trials for Hypocalcemia in Pregnancy
Active, not recruitingPhase 3
Efficacy and Safety of Encaleret Compared to Standard of Care in Participants With ADH1
Autosomal Dominant Hypocalcemia (ADH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tachjaree Panchalee, MD study director
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium supplement in people with Hypocalcemia in Pregnancy, run by Siriraj Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of hypocalcemia in pregnant women at Siriraj Hospital (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.