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BMI-based Vitamins in Obese Pregnant Women

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ClinicalTrials.gov Identifier: NCT02802566
Recruitment Status : Unknown
Verified June 2016 by Sarbattama Sen, Brigham and Women's Hospital.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Sarbattama Sen, Brigham and Women's Hospital

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 in pregnancies complicated by obesity.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: BMI-based prenatal vitamin Dietary Supplement: Standard prenatal vitamin Not Applicable

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 primary outcomes are maternal systemic markers of inflammation and oxidative stress. 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 success, and the following infant outcomes over the first year: neurodevelopmental outcome, growth trajectories and adiposity, systemic markers of inflammation and oxidative stress.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy
Study Start Date : December 2014
Estimated Primary Completion Date : July 2017

Arm Intervention/treatment
Experimental: Investigative
This arm receives a standard prenatal (provided by the study) and a micronutrient supplement.
Dietary Supplement: BMI-based prenatal vitamin
The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women.

Active Comparator: Control
Standard prenatal vitamin provided by the study
Dietary Supplement: Standard prenatal vitamin
Standard prenatal vitamin




Primary Outcome Measures :
  1. Maternal systemic marker of inflammation [ Time Frame: 35-40 weeks of pregnancy ]
    Serum C Reactive Protein

  2. Maternal systemic marker of oxidative stress [ Time Frame: 35-40 weeks of pregnancy ]
    Urinary 8-Oh-dG


Secondary Outcome Measures :
  1. Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]
    Plasma Vitamin C

  2. Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]
    Serum Vitamin E

  3. Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]
    Serum and Red Blood Cell folate

  4. Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]
    Serum Vitamin B6

  5. Cord blood marker of inflammation [ Time Frame: Delivery ]
    Serum C Reactive Protein

  6. Cord blood markers of oxidative stress [ Time Frame: Delivery ]
    8-epi-PGF2 alpha

  7. Breastfeeding success [ Time Frame: two, six and twelve months postpartum ]
    Complete questionnaire on infant feeding

  8. Infant weight [ Time Frame: birth, 6 months and one year ]
    Measure infant weight (kg)

  9. Infant length [ Time Frame: birth, six months and one year ]
    length (cm) measured using a length board

  10. Infant head circumference [ Time Frame: birth, six months and one year ]
    head circumference (cm) will be measured using tape measure technique

  11. Infant adiposity [ Time Frame: birth, six months and one year ]
    adiposity by peapod measurement at birth and by skin fold thickness at birth, six months and one year

  12. Infant marker of inflammation [ Time Frame: 1 year ]
    Serum C Reactive Protein



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02802566


Contacts
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Contact: Sarbattama Sen, MD (617)525-4123 ssen2@partners.org

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Mary Herlihy, MD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Sarbattama Sen, MD       ssen2@partners.org   
Contact: Annie Penfield-Cyr, BS       apenfield-cyr@partners.org   
Sponsors and Collaborators
Brigham and Women's Hospital
Beth Israel Deaconess Medical Center

Publications:
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Responsible Party: Sarbattama Sen, Assistant Professor of Pediatrics, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02802566     History of Changes
Other Study ID Numbers: 2014P001393
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sarbattama Sen, Brigham and Women's Hospital:
Maternal Obesity
Inflammation

Additional relevant MeSH terms:
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Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs