Effects of calcium supplementation in the prevention of preeclampsia in hypertensive pregnant women.
- Conditions
- O00-O99Pregnancy-Induced Hypertension
- Registration Number
- RBR-9ngb95
- Lead Sponsor
- niversidade Federal de São Paulo
- Brief Summary
Pregnant women with hypertensive disorders are at increased risk of chronic inflammation, cardiovascular disease, endothelial dysfunction, dyslipidemia, preeclampsia, among other events. The dilemma posed by the best dosage of calcium supplementation on these factors is evident. This study aimed to analyze the effects of calcium supplementation on blood pressure levels and proteinuria, as well as cardiovascular and inflammatory markers over time, comparing the use of high and low-dose calcium in hypertensive pregnant women from June 2018 to July. de 2019. This is a randomized clinical trial with three parallel groups, placebo controlled, carried out at the referral outpatient clinic for high-risk prenatal care in the southern region of Brazil with a three-stage follow-up analysis. The intervention consisted of calcium intake 500mg/day, calcium 1,500mg/day and placebo. Data were analyzed according to a generalized mixed equation estimation model adopting a 0.05. The effect of low- and high-dose calcium on outcome over time was maintained between groups, even after adjusting for confounders. There was a significant difference in the parameters analyzed in the time and group interaction (p <0.000). In the intragroup evaluation, we observed a decrease in the means of 12.3 mmHg in SBP (p intragroup =0.000), 9.2 mmHg in DBP (p intragroup =0.000), 36 mg/dl triglyceride (p intragroup =0.017) and 8.8 mg/ dl hs-CRP (p intragroup =0.000), 37 mg/dl creatinine (p intergroup 0.002), 4.8 mg/dl proteinuria (p intergroup 0.000), 4.5 pg/dl PTH (p intergroup 0.009). After 8 weeks of supplement use, the differences were in the mean blood pressure levels and other cardiovascular risk markers in both intervention groups, when compared with the placebo group. At the end of treatment, there was a significant reduction of 8.4 mmHg in SBP and 7.1 mmHg in DBP for the calcium 500mg/day group and a reduction of 10.9 mmHg in SBP and 8.8 mmHg in DBP for the group calcium 1,500mg/day. Calcium improved cardiovascular prognosis in hypertensive pregnant women by reducing blood pressure levels, inflammatory markers and adjusting the lipid profile. Daily calcium supplementation seems to be favorable even in short-term use and low dosage in women with low dietary nutrient intake and in developing countries.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Data analysis completed
- Sex
- Female
- Target Recruitment
- Not specified
Pregnant women over 18 years of age; single fetus; primigravidae; diagnosis of gestational hypertension; overweight and/or obesity; be at least 20 weeks pregnant; low socioeconomic factor; low dietary calcium intake (less than 800mg/day); non-use of drugs that interfere with calcium absorption (corticosteroids; thiazides; thyroid hormones)
Pregnant women with polyhydramnios; severe anemia; fetal death; severe preeclampsia; history of hypertension before pregnancy; placental abruption; premature rupture of membranes; abnormal umbilical artery doppler; uteroplacental insufficiency; other pre-existing medical condition; any contraindication to calcium supplementation
Study & Design
- Study Type
- Intervention
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method