Clinical trial

BMI-based Vitamins in Obese Pregnant Women

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT02802566

Active, not recruitingNot applicableInterventional

What this study is about

The purpose of this study is to devise and pilot a BMI-based prenatal vitamin for obese pregnant women. Currently, all pregnant women, regardless of body mass index, take the same prenatal vitamin. The investigators have found that obese pregnant women have higher levels of inflammation and oxidative stress, and a concomitant depletion of specific antioxidant micronutrients. The investigators have also found, in an animal model, that decreasing inflammation and oxidative stress during obese pregnancy was associated with improved offspring outcomes. Here the investigators aim to understand whether a BMI-based prenatal vitamin is effective in decreasing markers of inflammation and oxidative stress by raising concentrations of antioxidant micronutrients and in pregnancies complicated by obesity.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexFemale

Healthy volunteersAccepted

ConditionObesity

Full registry criteria

Inclusion Criteria: * Pre-pregnancy weight or early first trimester weight (BMI \> or equal to 30 kg/m2) * Women can be either planning pregnancy (who are trying to conceive or will be trying to conceive in the coming 6 months) or \<14 weeks pregnant Exclusion Criteria: * More than two first trimester pregnancy losses * History of delivering an infant with a major congenital anomaly * Pre-existing diabetes * Autoimmune disease such as lupus * Chronic inflammatory condition such as rheumatoid arthritis * Uncontrolled stage two or three hypertension at baseline (systolic\>160 or diastolic\>100 mmHg) * On anticoagulant therapy * History of cigarette smoking within the past 12 months * Lactose intolerant * Vegan * Unwilling to stop taking their current supplements

Treatments and study arms

BMI-based prenatal vitamin

Dietary Supplement

The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women.

Standard prenatal vitamin

Dietary Supplement

Standard prenatal vitamin

Primary outcomes

Maternal systemic marker of inflammation35-40 weeks of pregnancy

Serum C Reactive Protein

Maternal systemic marker of oxidative stress35-40 weeks of pregnancy

Urinary 8-Oh-dG

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Beth Israel Deaconess Medical Center🇺🇸 Boston, Massachusetts, United States

Open map

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

Open map