PregnancyPhase 4CARE PilotNCT07784218
Efficacy and Safety of Low-dose Calcium Supplementation in Pregnancy
A Phase 4 study testing Calcium in people with Pregnancy, run by First People's Hospital of Hangzhou at 1 site in China.
Trial summary
This study is a prospective, randomized, double-blind controlled pilot trial designed to comprehensively evaluate the efficacy and safety of a targeted low-dose (300 mg/day) versus a standard high-dose (600 mg/day) calcium supplementation during mid-to-late pregnancy. Read more about this study
- Who is it for?
- Ages 14 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- Calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 8 Jul 2026
- Phase
- Phase 4
- 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 14 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women aged 18 to 45 years
- Gestational age between 22 and 28 weeks
- Body mass index (BMI) between 19.0~28.0 kg/m2
- Willingness to comply with the study protocol and provision of informed consent
Who cannot join
- Known hypersensitivity or allergy to any active components or excipients of the study medications
- Multifetal gestation
- History of chronic constipation or functional defecation disorders prior to or during early pregnancy
- Current clinical hypercalcemia, hyperuricemia, familial hyperlipidemia, or intestinal malabsorption disorders
- History of prolonged extreme low-calcium diets or severe diagnosed nutritional deficiencies
- History of illicit substance abuse, chronic alcoholism, heavy smoking, or excessive caffeine intake
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Low-dose CAlcium Supplementation in pREgnancy: a Pilot Study (CARE Pilot)
This study is a prospective, randomized, double-blind controlled pilot trial designed to comprehensively evaluate the efficacy and safety of a targeted low-dose (300 mg/day) versus a standard high-dose (600 mg/day) calcium supplementation during mid-to-late pregnancy. The main research content is divided into the following four core dimensions:
- Evaluation of Maternal Skeletal and Systemic Calcium Efficacy: The core efficacy evaluation focuses on the preservation of maternal bone mineral density throughout mid-to-late pregnancy. This is assessed by the change in the BMD Z-score (ΔZ-score) from baseline to delivery using quantitative ultrasound (QUS). Concurrently, by comparing pre- and post-intervention maternal serum total calcium concentrations, the study verifies whether the low-dose regimen is sufficient to maintain normal systemic calcium homeostasis and support fetal development.
- Safety Assessment of Renal Filtration and Metabolic Burden: To investigate the potential metabolic toxicity of high-dose calcium, the study explicitly evaluates the maternal renal calcium excretion burden. By measuring the change in the fasting urinary calcium-to-creatinine ratio (ΔU-Ca/Cr) before and after the intervention, the research aims to determine whether the targeted low-dose regimen effectively prevents iatrogenic absorptive hypercalciuria induced by excessive calcium overload.
- Evaluation of Clinical Gastrointestinal Tolerability: Given that gastrointestinal adverse events are the primary deterrent to prenatal supplement adherence, this study utilizes the internationally recognized Rome IV criteria to rigorously track and compare the time-to-onset and cumulative incidence of moderate-to-severe constipation between the two groups, thereby quantifying the difference in intestinal tolerability between the dosages.
- Exploration of Adverse Pregnancy Outcomes and General Safety: As an exploratory clinical endpoint, the study records and compares the incidence rates of preeclampsia and preterm birth between the two intervention arms to ensure the low-dose regimen safely maintains prophylactic benefits against adverse obstetric outcomes. Furthermore, a comprehensive panel of maternal general laboratory parameters (e.g., hepatic and renal function, lipid profiles, and hematology) is monitored throughout to guarantee overall systemic safety.
- Conditions
- Pregnancy
- Being tested
- Calcium
- Keywords
- Pregnancy, Calcium Supplementation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalciumDrug
Participants in the treatment group received calcium 300 mg/day and the control group received calcium 600 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Calcium supplementation 300 mg/day Receives: Drug: Calcium |
| Control | Active comparator | Calcium supplementation 600 mg/day Receives: Drug: Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
ΔZ-score
Change in Bone Mineral Density (BMD) Z-score from baseline to delivery measured by Quantitative Ultrasound (QUS)
Measured: Baseline and before delivery
Moderate-to severe constipation
Time-to-onset and cumulative incidence of moderate-to-severe constipation (Rome IV criteria)
Measured: Through study completion, an average of 20 weeks
Secondary outcomes (2)
Serum calcium
Measured: Baseline and before delivery
ΔU-Ca/Cr
Change in urinary calcium-to-creatinine ratio
Measured: Baseline and before delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start10 Sep 2025
- Primary completion20 May 2026
- Study completion8 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- First People's Hospital of Hangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dandan Chen, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784218
- Sponsor's protocol ID
- CARE Pilot
- Acronym
- CARE Pilot
- Status last verified
- Aug 2026
- First submitted
- 17 Aug 2026
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-dose CAlcium Supplementation in pREgnancy: a Pilot Study (CARE Pilot)
- ClinicalTrials.gov ID
- NCT07784218
- Acronym / sponsor ID
- CARE Pilot / CARE Pilot
- Conditions
- Pregnancy
- Keywords
- Pregnancy, Calcium Supplementation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- First People's Hospital of HangzhouUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 8 Jul 2026 (actual)
- First posted
- 25 Aug 2026 (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.
This study is a prospective, randomized, double-blind controlled pilot trial designed to comprehensively evaluate the efficacy and safety of a targeted low-dose (300 mg/day) versus a standard high-dose (600 mg/day) calcium supplementation during mid-to-late pregnancy. The main research content is divided into the following four core dimensions:
- Evaluation of Maternal Skeletal and Systemic Calcium Efficacy: The core efficacy evaluation focuses on the preservation of maternal bone mineral density throughout mid-to-late pregnancy. This is assessed by the change in the BMD Z-score (ΔZ-score) from baseline to delivery using quantitative ultrasound (QUS). Concurrently, by comparing pre- and post-intervention maternal serum total calcium concentrations, the study verifies whether the low-dose regimen is sufficient to maintain normal systemic calcium homeostasis and support fetal development.
- Safety Assessment of Renal Filtration and Metabolic Burden: To investigate the potential metabolic toxicity of high-dose calcium, the study explicitly evaluates the maternal renal calcium excretion burden. By measuring the change in the fasting urinary calcium-to-creatinine ratio (ΔU-Ca/Cr) before and after the intervention, the research aims to determine whether the targeted low-dose regimen effectively prevents iatrogenic absorptive hypercalciuria induced by excessive calcium overload.
- Evaluation of Clinical Gastrointestinal Tolerability: Given that gastrointestinal adverse events are the primary deterrent to prenatal supplement adherence, this study utilizes the internationally recognized Rome IV criteria to rigorously track and compare the time-to-onset and cumulative incidence of moderate-to-severe constipation between the two groups, thereby quantifying the difference in intestinal tolerability between the dosages.
- Exploration of Adverse Pregnancy Outcomes and General Safety: As an exploratory clinical endpoint, the study records and compares the incidence rates of preeclampsia and preterm birth between the two intervention arms to ensure the low-dose regimen safely maintains prophylactic benefits against adverse obstetric outcomes. Furthermore, a comprehensive panel of maternal general laboratory parameters (e.g., hepatic and renal function, lipid profiles, and hematology) is monitored throughout to guarantee overall systemic safety.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: CalciumCalcium supplementation 300 mg/day |
| Control | Active comparator | Drug: CalciumCalcium supplementation 600 mg/day |
Who may qualify
- Ages
- 14 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Pregnant women aged 18 to 45 years
- Gestational age between 22 and 28 weeks
- Body mass index (BMI) between 19.0~28.0 kg/m2
- Willingness to comply with the study protocol and provision of informed consent
Key exclusion criteria (6 listed)
- Known hypersensitivity or allergy to any active components or excipients of the study medications
- Multifetal gestation
- History of chronic constipation or functional defecation disorders prior to or during early pregnancy
- Current clinical hypercalcemia, hyperuricemia, familial hyperlipidemia, or intestinal malabsorption disorders
- History of prolonged extreme low-calcium diets or severe diagnosed nutritional deficiencies
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 |
|---|---|---|
| CalciumParticipants in the treatment group received calcium 300 mg/day and the control group received calcium 600 mg/day. | Drug | Control, Treatment |
Primary outcome
ΔZ-score
Time frame: Baseline and before delivery
Change in Bone Mineral Density (BMD) Z-score from baseline to delivery measured by Quantitative Ultrasound (QUS)
Moderate-to severe constipation
Time frame: Through study completion, an average of 20 weeks
Time-to-onset and cumulative incidence of moderate-to-severe constipation (Rome IV criteria)
2 secondary outcomes
Serum calcium
Time frame: Baseline and before delivery
ΔU-Ca/Cr
Time frame: Baseline and before delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Calcium in people with Pregnancy, run by First People's Hospital of Hangzhou at 1 site in China.
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 4 inclusion and 6 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: finished, as of the sponsor's last update on 25 Aug 2026. 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 China. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ΔZ-score (time frame: Baseline and before delivery). The study lists 2 primary outcomes in all. 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 25 Aug 2026.