BMI-based Vitamins in Obese Pregnant Women

NCT02802566 | Active Not Recruiting

• 1 other identifier: 2014P001393
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity

Keywords

Maternal Obesity; Inflammation

Outcome Measures

Primary Outcomes (2)

• Maternal systemic marker of inflammation

  Serum C Reactive Protein

  35-40 weeks of pregnancy

• Maternal systemic marker of oxidative stress

  Urinary 8-Oh-dG

  35-40 weeks of pregnancy

Secondary Outcomes (12)

• Maternal antioxidant vitamins

  35-40 weeks of pregnancy

• Maternal antioxidant vitamins

  35-40 weeks of pregnancy

• Maternal antioxidant vitamins

  35-40 weeks of pregnancy

• Maternal antioxidant vitamins

  35-40 weeks of pregnancy

• Cord blood marker of inflammation

  Delivery

Study Arms (2)

Investigative

EXPERIMENTAL

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

Dietary Supplement: BMI-based prenatal vitamin

Control

ACTIVE COMPARATOR

Standard prenatal vitamin provided by the study

Dietary Supplement: Standard prenatal vitamin

Interventions

BMI-based prenatal vitamin DIETARY_SUPPLEMENT

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

Investigative

Standard prenatal vitamin DIETARY_SUPPLEMENT

Standard prenatal vitamin

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Beth Israel Deaconess Medical Center: collaborator

Study Sites (2)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 20823102 BACKGROUND

• 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.

  PMID: 24355940 BACKGROUND

• 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.

  PMID: 26741571 BACKGROUND

• 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.

  PMID: 38396126 DERIVED

MeSH Terms

Conditions

Obesity; Pregnancy in Obesity; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes

Study Officials

• SARBATTAMA SEN

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatrics

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 16, 2016
• Study Start: December 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: December 31, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be shared after publication of primary outcomes manuscript for a period of ten years.
• Access Criteria: Investigators requesting access will be asked to submit a proposal and analysis plan to analyze the requested data, including plans for dissemination and authorship.

Locations

US (2)