ObesityNCT02802566
BMI-based Vitamins in Obese Pregnant Women
A study testing BMI-based prenatal vitamin and Standard prenatal vitamin in people with Obesity, run by Brigham and Women's Hospital at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- BMI-based prenatal vitamin and Standard prenatal vitamin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2014to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- On anticoagulant therapy
- History of cigarette smoking within the past 12 months
- Lactose intolerant
- Vegan
- Unwilling to stop taking their current supplements
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy
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.
Read the 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.
- Conditions
- Obesity
- Being tested
- BMI-based prenatal vitamin, Standard prenatal vitamin
- Keywords
- Maternal Obesity, Inflammation
- Medical subject headings
- Obesity, Pregnancy in Obesity, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMI-based prenatal vitaminDietary supplement
The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women.
Standard prenatal vitaminDietary supplement
Standard prenatal vitamin
| Study group | Role | What they receive |
|---|---|---|
| Investigative | Experimental | This arm receives a standard prenatal (provided by the study) and a micronutrient supplement. Receives: Dietary Supplement: BMI-based prenatal vitamin |
| Control | Active comparator | Standard prenatal vitamin provided by the study Receives: Dietary Supplement: Standard prenatal vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal systemic marker of inflammation
Serum C Reactive Protein
Measured: 35-40 weeks of pregnancy
Maternal systemic marker of oxidative stress
Urinary 8-Oh-dG
Measured: 35-40 weeks of pregnancy
Secondary outcomes (12)
Maternal antioxidant vitamins
Plasma Vitamin C
Measured: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Serum Vitamin B6
Measured: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Serum Vitamin E
Measured: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Serum and Red Blood Cell folate
Measured: 35-40 weeks of pregnancy
Cord blood marker of inflammation
Serum C Reactive Protein
Measured: Delivery
Cord blood markers of oxidative stress
8-epi-PGF2 alpha
Measured: Delivery
Breastfeeding intensity
Complete questionnaire on infant feeding
Measured: two, six and twelve months postpartum
Infant weight
Measure infant weight (kg)
Measured: birth, 6 months and one year
Infant length
length (cm) measured using a length board
Measured: birth, six months and one year
Infant head circumference
head circumference (cm) will be measured using tape measure technique
Measured: birth, six months and one year
Infant adiposity
adiposity by peapod measurement at birth and by skin fold thickness at birth, six months and one year
Measured: birth, six months and one year
Infant marker of inflammation
Serum C Reactive Protein
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionSep 2017
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Responsible party
- Principal investigator, Sarbattama Sen, Brigham and Women's Hospital
- Investigators
- SARBATTAMA SEN, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802566
- Sponsor's protocol ID
- 2014P001393
- Status last verified
- Dec 2024
- First submitted
- 26 May 2016
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Non-PHI, deidentified IPD will be shared with requesting investigators. A limited data set, generated based on variables identified in an analysis plan approved by PNV investigators, will be sent via secure email or shared dropbox to requesting investigators.
Publications
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.
PubMed 20823102Sen 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.
PubMed 24355940Panagos 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.
PubMed 26741571Sen S, Cherkerzian S, Herlihy M, Hacker MR, McElrath TF, Cantonwine DE, Fichorova R, Oken E, Meydani SN. Supplementation with antioxidant micronutrients in pregnant women with obesity: a randomized controlled trial. Int J Obes (Lond). 2024 Jun;48(6):796-807. doi: 10.1038/s41366-024-01472-z. Epub 2024 Feb 23.
PubMed 38396126
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BMI-Based Prenatal Vitamins to Ameliorate Oxidative Stress in Obese Pregnancy
- ClinicalTrials.gov ID
- NCT02802566
- Acronym / sponsor ID
- 2014P001393
- Conditions
- Obesity
- Keywords
- Maternal Obesity, Inflammation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center
- Study start
- Dec 2014
- Primary completion
- Sep 2017 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigative | Experimental | Dietary Supplement: BMI-based prenatal vitaminThis arm receives a standard prenatal (provided by the study) and a micronutrient supplement. |
| Control | Active comparator | Dietary Supplement: Standard prenatal vitaminStandard prenatal vitamin provided by the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMI-based prenatal vitaminThe intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women. | Dietary supplement | Investigative |
| Standard prenatal vitaminStandard prenatal vitamin | Dietary supplement | Control |
Primary outcome
Maternal systemic marker of inflammation
Time frame: 35-40 weeks of pregnancy
Serum C Reactive Protein
Maternal systemic marker of oxidative stress
Time frame: 35-40 weeks of pregnancy
Urinary 8-Oh-dG
12 secondary outcomes
Maternal antioxidant vitamins
Time frame: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Time frame: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Time frame: 35-40 weeks of pregnancy
Maternal antioxidant vitamins
Time frame: 35-40 weeks of pregnancy
Cord blood marker of inflammation
Time frame: Delivery
Cord blood markers of oxidative stress
Time frame: Delivery
Breastfeeding intensity
Time frame: two, six and twelve months postpartum
Infant weight
Time frame: birth, 6 months and one year
Infant length
Time frame: birth, six months and one year
Infant head circumference
Time frame: birth, six months and one year
Infant adiposity
Time frame: birth, six months and one year
Infant marker of inflammation
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Background: PubMed 20823102Sen 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.
- Background: PubMed 24355940Sen 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.
- Background: PubMed 26741571Panagos 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.
- Derived from this study: PubMed 38396126Sen S, Cherkerzian S, Herlihy M, Hacker MR, McElrath TF, Cantonwine DE, Fichorova R, Oken E, Meydani SN. Supplementation with antioxidant micronutrients in pregnant women with obesity: a randomized controlled trial. Int J Obes (Lond). 2024 Jun;48(6):796-807. doi: 10.1038/s41366-024-01472-z. Epub 2024 Feb 23.
- Individual participant dataSharing planned: Yes. Non-PHI, deidentified IPD will be shared with requesting investigators. A limited data set, generated based on variables identified in an analysis plan approved by PNV investigators, will be sent via secure email or shared dropbox to requesting investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
SARBATTAMA SEN principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BMI-based prenatal vitamin and Standard prenatal vitamin in people with Obesity, run by Brigham and Women's Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal systemic marker of inflammation (time frame: 35-40 weeks of pregnancy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02802566, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024.