NCT02802566Active, not recruiting
BMI-based Vitamins in Obese Pregnant Women
BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy
Source: ClinicalTrials.gov · Last updated 10 Dec 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 146 (actual)
- First submitted
- 26 May 2016
- Start date
- Dec 2014
- Primary completion date
- Sept 2017
- Lead sponsor
- Brigham and Women's Hospital
- Diseases
- Obesity
- NCT number
- NCT02802566
What you commit to
- Study type: Interventional
- Participants enrolled: 146
- From Dec 2014 to the primary completion date, Sept 2017
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- On anticoagulant therapy
Other illness
- 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)
- History of cigarette smoking within the past 12 months
Other
- More than two first trimester pregnancy losses
- Lactose intolerant
- Vegan
- Unwilling to stop taking their current supplements
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Brigham and Women's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.