Clinical trial NCT02802566: BMI-based Vitamins in Obese Pregnant Women
Official title: BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: Maternal Obesity
Inflammation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2016-06-16
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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 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.

Eligibility 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

Primary outcomes:
measure: Maternal systemic marker of inflammation
timeFrame: 35-40 weeks of pregnancy
measure: Maternal systemic marker of oxidative stress
timeFrame: 35-40 weeks of pregnancy
Secondary outcomes:
measure: Maternal antioxidant vitamins
timeFrame: 35-40 weeks of pregnancy
measure: Maternal antioxidant vitamins
timeFrame: 35-40 weeks of pregnancy
measure: Maternal antioxidant vitamins
timeFrame: 35-40 weeks of pregnancy
measure: Maternal antioxidant vitamins
timeFrame: 35-40 weeks of pregnancy
measure: Cord blood marker of inflammation
timeFrame: Delivery
measure: Cord blood markers of oxidative stress
timeFrame: Delivery
measure: Breastfeeding intensity
timeFrame: two, six and twelve months postpartum
measure: Infant weight
timeFrame: birth, 6 months and one year
measure: Infant length
timeFrame: birth, six months and one year
measure: Infant head circumference
timeFrame: birth, six months and one year
measure: Infant adiposity
timeFrame: birth, six months and one year
measure: Infant marker of inflammation
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: SARBATTAMA SEN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.