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Vitamins and Minerals
Customized Prenatal Vitamins for Obesity during Pregnancy
N/A
Waitlist Available
Led By SARBATTAMA SEN
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether a prenatal vitamin customized for obese women can help decrease inflammation and stress during pregnancy.
Who is the study for?
This trial is for obese pregnant women or those planning pregnancy with a BMI of 30 kg/m2 or higher. It's not suitable for women who've had multiple early miscarriages, birth defects in previous pregnancies, autoimmune diseases, pre-existing diabetes, severe hypertension, recent smokers, vegans, those on certain medications like anticoagulants or unwilling to stop current supplements.Check my eligibility
What is being tested?
The study tests if a special prenatal vitamin tailored to body mass index (BMI) can reduce inflammation and oxidative stress in obese pregnant women better than the standard prenatal vitamin. The goal is to see if this new approach leads to healthier outcomes for both mother and child.See study design
What are the potential side effects?
While specific side effects are not detailed here as it's about vitamins intake adjustment based on BMI; generally speaking potential side effects may include gastrointestinal discomfort or allergic reactions.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Maternal systemic marker of inflammation
Maternal systemic marker of oxidative stress
Secondary outcome measures
Breastfeeding intensity
Cord blood marker of inflammation
Cord blood markers of oxidative stress
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: InvestigativeExperimental Treatment1 Intervention
This arm receives a standard prenatal (provided by the study) and a micronutrient supplement.
Group II: ControlActive Control1 Intervention
Standard prenatal vitamin provided by the study
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Who is running the clinical trial?
Beth Israel Deaconess Medical CenterOTHER
836 Previous Clinical Trials
13,010,190 Total Patients Enrolled
21 Trials studying Obesity
634 Patients Enrolled for Obesity
Brigham and Women's HospitalLead Sponsor
1,608 Previous Clinical Trials
11,469,731 Total Patients Enrolled
45 Trials studying Obesity
78,029 Patients Enrolled for Obesity
SARBATTAMA SENPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had more than two miscarriages in the first three months of pregnancy.You already have diabetes before the study.You have given birth to a baby with a serious birth defect.You have smoked cigarettes within the last year.You are not willing to stop taking your current dietary supplements.You are currently taking medicine to prevent blood clots.You have a disease that affects your immune system, like lupus.You follow a vegan diet.You have a long-lasting condition called rheumatoid arthritis that causes inflammation.You are unable to digest lactose (a sugar found in milk).
Research Study Groups:
This trial has the following groups:- Group 1: Investigative
- Group 2: Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the intended outcome of this experiment?
"This clinical trial, spanning 35-40 weeks of gestation, has the primary goal of assessing maternal systemic markers of inflammation. Secondary objectives include investigating breastfeeding success through a completed questionnaire, cord blood markers of oxidative stress using 8-epi-PGF2 alpha levels as an indicator and infant marker or inflammation via Serum C Reactive Protein testing."
Answered by AI
Is this medical study taking on new participants at the present time?
"Contrary to expectation, clinicaltrials.gov discloses that this biomedical research is not accepting candidates at present; the trial was initially posted on December 1st 2014 and last modified on December 6th 2021. Despite this lack of registration opportunities, there are presently 956 other studies actively enrolling participants."
Answered by AI
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