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Clinical Trials in Israel / NCT02802566
Active, not recruiting Not applicable

BMI-based Vitamins in Obese Pregnant Women

NCT02802566 · tracked via the Priya Life Science Israel tracker
Sponsor
Brigham and Women's Hospital
Phase
Not applicable
Started
2014-12
Last updated
2024-12-10

Condition(s) studied

Obesity

Investigational drug(s) / intervention(s)

BMI-based prenatal vitaminStandard prenatal vitamin

BMI-based prenatal vitamin: The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women.

Standard prenatal vitamin: Standard prenatal vitamin

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Beth Israel Deaconess Medical Center Boston Massachusetts
Brigham and Women's Hospital Boston Massachusetts

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Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS) Starting soon
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02802566 on ClinicalTrials.gov ↗ ← All trials in Israel