Customized Prenatal Vitamins for Obesity during Pregnancy

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

146 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 'Customized Prenatal Vitamins for Obesity during Pregnancy'?

The research does not provide direct evidence on the effectiveness of customized prenatal vitamins for obesity during pregnancy, but one study suggests that vitamin B12 status is important in pregnancy and may be related to obesity and gestational diabetes, which could imply a potential role for vitamins in managing these conditions. ^{1 2 3 4 5}

Is it safe to take customized prenatal vitamins for obesity during pregnancy?

Research shows that taking folic acid, vitamin D, and iodine supplements is common and generally safe for pregnant women with obesity, but many do not meet the recommended higher doses. It's important to follow guidance on supplement use to ensure safety and effectiveness. ^{1 5 6 7 8}

How do customized prenatal vitamins for obesity during pregnancy differ from other treatments?

Customized prenatal vitamins for obesity during pregnancy are unique because they are tailored to the specific needs of women with higher body mass index (BMI), focusing on higher doses of essential nutrients like folate and vitamin D, which are often deficient in this group. This personalized approach aims to address the increased risk of nutrient deficiencies and associated complications in pregnant women with obesity. ^{5 6 9 10 11}

What is the purpose of this trial?

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.

Research Team

Sarbattama Sen, M.D.

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Little beneficial effect of maternal vitamin supplement on metabolic disturbances in the offspring from the obese mother mice. [2015]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Early intensive obstetric and medical nutrition care is associated with decreased prepregnancy obesity impact on perinatal outcomes. [2012]

3. United States pubmed.ncbi.nlm.nih.gov

Birthweight and pregnancy outcomes in obese class II women with low weight gain: A retrospective study. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Optimal Gestational Weight Gain for Women With Obesity. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Vitamin B12 Status among Pregnant Women in the UK and Its Association with Obesity and Gestational Diabetes. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Dietary Intakes of Folate, Vitamin D and Iodine during the First Trimester of Pregnancy and the Association between Supplement Use and Demographic Characteristics amongst White Caucasian Women Living with Obesity in the UK. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Early pregnancy serum levels of folate and vitamin B12 in overweight and obese women in Khartoum, Sudan. [2023]

8. Norway pubmed.ncbi.nlm.nih.gov

Maternal body mass index and the association between folic acid supplements and neural tube defects. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Enablers of and barriers to making healthy change during pregnancy in overweight and obese women. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Folate status in women of childbearing age with obesity: a review. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

Maternal obesity, folate intake, and neural tube defects in offspring. [2021]