Customized Prenatal Vitamins for Obesity during Pregnancy

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen BySarbattama Sen, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Brigham and Women's Hospital

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for obese pregnant women or those planning pregnancy with a BMI of 30 kg/m2 or higher. It's not suitable for women who've had multiple early miscarriages, birth defects in previous pregnancies, autoimmune diseases, pre-existing diabetes, severe hypertension, recent smokers, vegans, those on certain medications like anticoagulants or unwilling to stop current supplements.

Inclusion Criteria

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

Pre-pregnancy weight or early first trimester weight (BMI > or equal to 30 kg/m2)

Exclusion Criteria

You have had more than two miscarriages in the first three months of pregnancy.

You already have diabetes before the study.

You have given birth to a baby with a serious birth defect.

+8 more

Participant Groups

The study tests if a special prenatal vitamin tailored to body mass index (BMI) can reduce inflammation and oxidative stress in obese pregnant women better than the standard prenatal vitamin. The goal is to see if this new approach leads to healthier outcomes for both mother and child.

2Treatment groups

Experimental Treatment

Active Control

Group I: InvestigativeExperimental Treatment1 Intervention

This arm receives a standard prenatal (provided by the study) and a micronutrient supplement.

Group II: ControlActive Control1 Intervention

Standard prenatal vitamin provided by the study