BMI-based Vitamins in Obese Pregnant Women

NCT ID: NCT02802566

Last Updated: 2024-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

The investigators' central hypothesis is that pregnancy in obese women creates an oxidant/anti-oxidant imbalance, which adversely impacts maternal health and neonatal outcome. The investigators hypothesize that restoring oxidant/anti-oxidant balance with a body mass index (BMI) based prenatal micronutrient supplement will decrease oxidative stress. The investigators aim to devise a prenatal vitamin supplement based on maternal BMI to increase serum levels of antioxidant vitamins in obese pregnancy, to assess how the BMI-based prenatal vitamin supplementation impacts markers of oxidative stress and inflammation in obese pregnant women and to evaluate the effectiveness of this vitamin formulation in reducing oxidative stress and inflammation and improving growth trajectories in infants born to obese women.

The investigators will conduct a double-blind randomized-controlled study. Two groups of women will be randomized independently. 1) Obese women (BMI>30) planning pregnancy through the through advertising and mailings (N=50) and 2) Pregnant women who are early in pregnancy (<13 weeks) will be approached at their first prenatal visit at the BWH and BIDMC obstetric practices (N=120).

Women will be prescreened and approached by study staff if they qualify. After informed consent is obtained, patients will be randomized to either control or intervention group by computer-generated permuted block randomization. All subjects will be given a standard prenatal vitamin provided by the study and in addition, the control group will be given a placebo and the Intervention group will be given a supplement with vitamin C, E, B6 and folate.

The outcomes are maternal systemic markers inflammation and oxidative stress and micronutrients. At the time points mentioned above, the following laboratory assays will be conducted in maternal blood or urine: C reactive protein, vitamins C, E, B6, folate 8-iso-PGF2a and 8-OHdG. The secondary outcomes are cord blood markers of inflammation and oxidative stress, breastfeeding outcomes, and the following infant outcomes over the first year: neurodevelopmental outcome, growth trajectories and adiposity, systemic markers of inflammation and oxidative stress.

Conditions

Obesity

Keywords

Maternal Obesity; Inflammation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Investigative

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

Group Type: EXPERIMENTAL

BMI-based prenatal vitamin

Intervention Type: DIETARY_SUPPLEMENT

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

Control

Standard prenatal vitamin provided by the study

Group Type: ACTIVE_COMPARATOR

Standard prenatal vitamin

Intervention Type: DIETARY_SUPPLEMENT

Standard prenatal vitamin

Interventions

BMI-based prenatal vitamin

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

Intervention Type: DIETARY_SUPPLEMENT

Standard prenatal vitamin

Standard prenatal vitamin

Intervention Type: DIETARY_SUPPLEMENT

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sarbattama Sen

Assistant Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

SARBATTAMA SEN

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Sen S, Simmons RA. Maternal antioxidant supplementation prevents adiposity in the offspring of Western diet-fed rats. Diabetes. 2010 Dec;59(12):3058-65. doi: 10.2337/db10-0301. Epub 2010 Sep 7.

Reference Type: BACKGROUND

PMID: 20823102 (View on PubMed)

Sen S, Iyer C, Meydani SN. Obesity during pregnancy alters maternal oxidant balance and micronutrient status. J Perinatol. 2014 Feb;34(2):105-11. doi: 10.1038/jp.2013.153. Epub 2013 Dec 19.

Reference Type: BACKGROUND

PMID: 24355940 (View on PubMed)

Panagos PG, Vishwanathan R, Penfield-Cyr A, Matthan NR, Shivappa N, Wirth MD, Hebert JR, Sen S. Breastmilk from obese mothers has pro-inflammatory properties and decreased neuroprotective factors. J Perinatol. 2016 Apr;36(4):284-90. doi: 10.1038/jp.2015.199. Epub 2016 Jan 7.

Reference Type: BACKGROUND

PMID: 26741571 (View on PubMed)

Sen S, Cherkerzian S, Herlihy M, Hacker MR, McElrath TF, Cantonwine DE, Fichorova R, Oken E, Meydani SN. Supplementation with antioxidant micronutrients in pregnant women with obesity: a randomized controlled trial. Int J Obes (Lond). 2024 Jun;48(6):796-807. doi: 10.1038/s41366-024-01472-z. Epub 2024 Feb 23.

Reference Type: DERIVED

PMID: 38396126 (View on PubMed)

Other Identifiers

2014P001393

Identifier Type: -

Identifier Source: org_study_id