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BMI-based Vitamins in Obese Pregnant Women

NCT02802566 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-12-10

No results posted yet for this study

Summary

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

BMI-based prenatal vitamin

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

DIETARY_SUPPLEMENT

Standard prenatal vitamin

Standard prenatal vitamin

Sponsors & Collaborators

Principal Investigators

  • SARBATTAMA SEN · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-09-30
Completion
2025-12-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT02802566 on ClinicalTrials.gov