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Efficacy and Safety of Low-dose Calcium Supplementation in Pregnancy

NCT07784218 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2026-08-25

No results posted yet for this study

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. The main research content is divided into the following four core dimensions:

1. 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.
2. 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.
3. 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.
4. 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

Interventions

DRUG

Calcium

Participants in the treatment group received calcium 300 mg/day and the control group received calcium 600 mg/day.

Sponsors & Collaborators

  • First People's Hospital of Hangzhou

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-09-10
Primary Completion
2026-05-20
Completion
2026-07-08

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07784218 on ClinicalTrials.gov