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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigative | Experimental | This arm receives a standard prenatal (provided by the study) and a micronutrient supplement. |
|
| Control | Active Comparator | Standard prenatal vitamin provided by the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMI-based prenatal vitamin | Dietary Supplement | The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal antioxidant vitamins | Plasma Vitamin C | 35-40 weeks of pregnancy |
| Maternal antioxidant vitamins | Serum Vitamin B6 | 35-40 weeks of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| SARBATTAMA SEN | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02115 | United States | ||
| Brigham and Women's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20823102 | Background | 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. | |
| 24355940 | 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. |
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Non-PHI, deidentified IPD will be shared with requesting investigators. A limited data set, generated based on variables identified in an analysis plan approved by PNV investigators, will be sent via secure email or shared dropbox to requesting investigators.
Data will be shared after publication of primary outcomes manuscript for a period of ten years.
Investigators requesting access will be asked to submit a proposal and analysis plan to analyze the requested data, including plans for dissemination and authorship.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D000079262 | Pregnancy in Obesity |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Standard prenatal vitamin | Dietary Supplement | Standard prenatal vitamin |
|
| Maternal antioxidant vitamins | Serum Vitamin E | 35-40 weeks of pregnancy |
| Maternal antioxidant vitamins | Serum and Red Blood Cell folate | 35-40 weeks of pregnancy |
| Cord blood marker of inflammation | Serum C Reactive Protein | Delivery |
| Cord blood markers of oxidative stress | 8-epi-PGF2 alpha | Delivery |
| Breastfeeding intensity | Complete questionnaire on infant feeding | two, six and twelve months postpartum |
| Infant weight | Measure infant weight (kg) | birth, 6 months and one year |
| Infant length | length (cm) measured using a length board | birth, six months and one year |
| Infant head circumference | head circumference (cm) will be measured using tape measure technique | birth, six months and one year |
| Infant adiposity | adiposity by peapod measurement at birth and by skin fold thickness at birth, six months and one year | birth, six months and one year |
| Infant marker of inflammation | Serum C Reactive Protein | 1 year |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| 26741571 | 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. |
| 38396126 | Derived | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D010335 | Pathologic Processes |