Customized Prenatal Vitamins for Obesity during Pregnancy

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Anticoagulants

Disqualifiers: Diabetes, Autoimmune, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 35-40 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new prenatal vitamin specifically designed for pregnant women with obesity. Researchers aim to determine if these vitamins can reduce inflammation and stress, which tend to be higher in obese pregnancies. The study will compare a special vitamin blend (BMI-based prenatal vitamin) with regular prenatal vitamins to assess effectiveness. Women trying to conceive or who are less than 14 weeks pregnant with a BMI of 30 or higher may be suitable candidates. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance prenatal care for women with obesity.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must be willing to stop taking your current supplements to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that taking supplements like folic acid, vitamin D, and iodine is common and generally safe for pregnant women with obesity. However, many do not receive enough of these essential nutrients. This is important because obesity can increase the risk of complications during pregnancy. Studies have also linked prenatal vitamins containing multiple micronutrients to a lower risk of low birth weight in babies.

The new prenatal vitamin, designed for women with higher body mass indexes (BMIs), aims to provide the right nutrients. Although specific safety data for this exact vitamin is not available, its ingredients, such as vitamin D and folic acid, are well-known and typically safe. This should reassure those considering joining the study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BMI-based prenatal vitamin because it offers a tailored approach to prenatal care for individuals with obesity during pregnancy. Unlike standard prenatal vitamins that use a one-size-fits-all formula, this treatment customizes the nutrient composition based on body mass index (BMI), potentially addressing unique nutritional needs. This personalized method could optimize maternal and fetal health outcomes by ensuring that essential micronutrients are delivered in appropriate amounts for those with higher BMIs.

What evidence suggests that a BMI-based prenatal vitamin could be effective for obesity during pregnancy?

Research shows that pregnant women with obesity often experience increased inflammation and stress in their bodies, placing them under more strain compared to women with lower body weight. One study found that obesity before pregnancy can raise the risk of vitamin deficiencies, complicating pregnancies. In animal studies, reducing inflammation and stress during pregnancy led to better outcomes for the offspring. This trial will compare two approaches: one group will receive a BMI-based prenatal vitamin designed to lower stress levels by providing essential nutrients, potentially leading to healthier pregnancies for women with higher BMIs. The control group will receive a standard prenatal vitamin. ^{1 3 4 6 7}

Who Is on the Research Team?

Sarbattama Sen, M.D.

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

Pre-pregnancy weight or early first trimester weight (BMI > or equal to 30 kg/m2)

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a standard prenatal vitamin with a placebo or a BMI-based micronutrient supplement

35-40 weeks

Regular prenatal visits

Follow-up

Participants are monitored for safety and effectiveness after treatment, including infant growth and development

1 year

Visits at birth, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

• BMI-based prenatal vitamin
• Standard prenatal vitamin

Trial Overview 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.

How Is the Trial Designed?

Group I: Investigative Experimental Treatment 1 Intervention

This arm receives a standard prenatal (provided by the study) and a micronutrient supplement.

Group II: Control Active Control 1 Intervention

Standard prenatal vitamin provided by the study

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

In a study of 16,808 women with obesity, a gestational weight change of -1 to +4 kg was found to significantly reduce the risk of major neonatal morbidity compared to the current recommended weight gain guidelines.

Women with class II and III obesity may benefit from even lower weight gain during pregnancy, with optimal ranges of -2 to +2 kg and -2 to +3 kg respectively, indicating that tailored weight management strategies could improve maternal and neonatal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. Bujold, L., Audibert, F., Chaillet, N.[2023]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002916523037176

Effects of prenatal nutritional supplements on gestational ... Outcome metrics​​ The recommended rates of GWG for the second and third trimesters were 0.51, 0.42, 0.28, and 0.22 kg/wk for women with underweight, normal ...

2. nature.com nature.com/articles/s41598-021-97635-3

The effect of prepregnancy body mass index on maternal ... The pooled results from three included studies suggested that prepregnancy obesity (BMI > 30) contributed to an increased risk of vitamin ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4989730/

Obesity in pregnancy: risks and management - PubMed Central Overall, however, it is clear that higher pre-pregnancy BMI is associated with an increased risk of a number of pregnancy complications and adverse pregnancy ...

4. withpower.com withpower.com/trial/phase-obesity-11-2014-43038

Customized Prenatal Vitamins for Obesity during Pregnancy Here the investigators aim to understand whether a BMI-based prenatal vitamin is effective in decreasing markers of inflammation and oxidative stress by ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9275129/

Evidence based recommendations for an optimal prenatal ... Vitamin D supplementation of 400–600 IU/day during pregnancy has been shown to significantly reduce the risk of preeclampsia by 29% after cofounder adjustment [ ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10843965/

Effects of prenatal nutritional supplements on gestational ... Data from previous meta-analyses have shown that, compared with iron and folic acid supplements, prenatal MMSs decrease the risk of low birth weight and small- ...

7. ajog.org ajog.org/article/S0002-9378(22)00285-X/fulltext

Maternal obesity during pregnancy leads to derangements ... Maternal obesity during pregnancy leads to derangements in one-carbon metabolism and the gut microbiota: implications for fetal development and offspring ...