BMI-based Vitamins in Obese Pregnant Women
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Maternal systemic marker of inflammation [35-40 weeks of pregnancy]
Serum C Reactive Protein
- Maternal systemic marker of oxidative stress [35-40 weeks of pregnancy]
Urinary 8-Oh-dG
Secondary Outcome Measures
- Maternal antioxidant vitamins [35-40 weeks of pregnancy]
Plasma Vitamin C
- Maternal antioxidant vitamins [35-40 weeks of pregnancy]
Serum Vitamin E
- Maternal antioxidant vitamins [35-40 weeks of pregnancy]
Serum and Red Blood Cell folate
- Maternal antioxidant vitamins [35-40 weeks of pregnancy]
Serum Vitamin B6
- Cord blood marker of inflammation [Delivery]
Serum C Reactive Protein
- Cord blood markers of oxidative stress [Delivery]
8-epi-PGF2 alpha
- Breastfeeding success [two, six and twelve months postpartum]
Complete questionnaire on infant feeding
- Infant weight [birth, 6 months and one year]
Measure infant weight (kg)
- Infant length [birth, six months and one year]
length (cm) measured using a length board
- Infant head circumference [birth, six months and one year]
head circumference (cm) will be measured using tape measure technique
- Infant adiposity [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 [1 year]
Serum C Reactive Protein
Eligibility Criteria
Criteria
Inclusion Criteria:
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Pre-pregnancy weight or early first trimester weight (BMI > or equal to 30 kg/m2)
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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:
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More than two first trimester pregnancy losses
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History of delivering an infant with a major congenital anomaly
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Pre-existing diabetes
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Autoimmune disease such as lupus
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Chronic inflammatory condition such as rheumatoid arthritis
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Uncontrolled stage two or three hypertension at baseline (systolic>160 or diastolic>100 mmHg)
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On anticoagulant therapy
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History of cigarette smoking within the past 12 months
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Lactose intolerant
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Vegan
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Unwilling to stop taking their current supplements
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beth Israel Deaconess Medical Center | Boston | Massachusetts | United States | 02115 |
| 2 | Brigham and Women's Hospital | Boston | Massachusetts | United States | 02115 |
Sponsors and Collaborators
- Brigham and Women's Hospital
- Beth Israel Deaconess Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 2014P001393