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
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: BMI-based prenatal vitamin Dietary Supplement: Standard prenatal vitamin||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||July 2017|
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
- Maternal systemic marker of inflammation [ Time Frame: 35-40 weeks of pregnancy ]Serum C Reactive Protein
- Maternal systemic marker of oxidative stress [ Time Frame: 35-40 weeks of pregnancy ]Urinary 8-Oh-dG
- Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]Plasma Vitamin C
- Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]Serum Vitamin E
- Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]Serum and Red Blood Cell folate
- Maternal antioxidant vitamins [ Time Frame: 35-40 weeks of pregnancy ]Serum Vitamin B6
- Cord blood marker of inflammation [ Time Frame: Delivery ]Serum C Reactive Protein
- Cord blood markers of oxidative stress [ Time Frame: Delivery ]8-epi-PGF2 alpha
- Breastfeeding success [ Time Frame: two, six and twelve months postpartum ]Complete questionnaire on infant feeding
- Infant weight [ Time Frame: birth, 6 months and one year ]Measure infant weight (kg)
- Infant length [ Time Frame: birth, six months and one year ]length (cm) measured using a length board
- Infant head circumference [ Time Frame: birth, six months and one year ]head circumference (cm) will be measured using tape measure technique
- 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
- Infant marker of inflammation [ Time Frame: 1 year ]Serum C Reactive Protein
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
|Contact: Sarbattama Sen, MD||(617)email@example.com|
|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 firstname.lastname@example.org|
|Contact: Annie Penfield-Cyr, BS email@example.com|