Vitamin B 12 DeficiencyNCT06046703
Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet
An observational study of Vitamin B 12 Deficiency and Pregnancy, run by Maastricht University Medical Center.
Trial summary
The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet. The main aim is to compare vitamin B12 intake. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vitamin B 12 Deficiency, Pregnancy, Nutrient Deficiency
- What is being tested?
- Daily nutritional intake
- How many people
- 256 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 1 Jul 2027
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women from the Netherlands
Who may be able to join
- Before 27 weeks of pregnancy
- Age >18 years
- Strict plant-based diet (vegan diet), defined as a diet without ingestion of animal products (i.e., intake less than once a month during) the entire pregnancy or omnivorous diet, defined as a diet that includes meat
- Willing and able to give written informed consent and to understand, participate and comply with the research project requirements
Who cannot join
- Food allergy that influences the nutritional intake, e.g., milk allergy, celiac disease, and lactose intolerance
- Medical history of gastrointestinal diseases such as Crohn's disease and other diseases associated with vitamin B12 deficiencies such as (pre-existing) diabetes.
- Medical history of abdominal surgery interfering with nutrient uptake, such as gastric bypass and intestinal resections
- Pre-existing cardio-vascular diseases or auto-immune diseases
- Insufficient understanding of the Dutch language
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet: a Focus on Vitamin B12 Intake and Other Nutritional and Pregnancy-related Outcomes
The goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet.
The main aim is to compare vitamin B12 intake.
Participants will be asked to:
- fill out a health questionnaire
- fill out a three-day food diary
- undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.
Read the detailed description
The number of people adhering to a strict plant-based diet is increasing globally. Adequate maternal nutrition during pregnancy is essential for fetal development, as deficiencies in macro- and micronutrients can cause maternal and neonatal complications. Nutrition can play a role in developing pre-eclampsia, premature birth, and intra-uterine growth restriction. Although there is evidence of nutrient deficiencies in people who follow a strict plant-based diet and the significance of maternal diet for both maternal and fetal outcomes, there has been limited research on the nutritional intake and outcomes of pregnant women on a strict plant-based diet. Additionally, to the best of our knowledge, very limited research has been published on the incidence of pregnancy-induced hypertension, pre-eclampsia, gestational diabetes, or pre-term birth in women on a strict plant-based diet. The relation between these outcomes and nutritional intake/status is also unknown in this specific group of women, even though the number of people with a strict plant-based diet is increasing. The only two studies that studied pregnancy-related outcomes in women on a strict plant-based diet were performed in Israel and were not powered to show statistical differences between a strict plant-based diet and obstetrical outcomes. Additionally, the dietary intake in Israel differs from other parts of the world. Thus, it is impossible to ascertain if the results also apply to a population with a distinct diet. Recently, the Royal Dutch Organization of Midwives (Koninklijke Nederlandse Organisatie van Verloskundigen, KNOV) published 'the guide for vegetarian and vegan diet in pregnancy .' They acknowledge the limited availability of scientific research concerning the strict plant-based diet in pregnancy and the non-existence of data on Dutch pregnant women. They recommend performing additional blood tests for vitamin B12 and D in case of possible nutrition deficiencies in this group of pregnant women. A significantly lower ferritin level is also described in pregnant women on a strict plant-based diet. In conclusion, even though the nutritional intake during pregnancy is vital for both mother and child, the nutritional intake amongst Dutch women on a strict plant-based diet during pregnancy is unknown. Previously published results from Israeli women do not apply to the Dutch population, as nutritional intake differs between countries. The recently published KNOV guide suggests checking vitamin blood levels during pregnancy. To advise and update guidelines for Dutch women on a strict plant-based diet during pregnancy, additional research on nutritional intake and the nutritional status of Dutch women on a strict plant-based diet and to compare this with nutritional status of omnivorous pregnant women is crucial.
The participant will complete a health-related questionnaire. The estimated time required to complete the questionnaire is approximately 10 minutes. Additionally, between 27 and 30 weeks of pregnancy, participants will fill out a three-day food diary. It is estimated that the questionnaire will take approximately 30 minutes to complete each day. Finally, the participants must complete a questionnaire following the baby's delivery. This questionnaire will cover various aspects, such as the pregnancy, delivery, and blood results obtained during pregnancy. The estimated time required to complete the questionnaire is approximately 15 minutes.
During the blood sampling, 10 ml of blood will be collected using an evacuated tube system through venepuncture. Taking blood samples is a routine part of clinical practice, not solely for this study. Pregnant women typically undergo venipuncture between 27 and 30 weeks as part of regular obstetrical care.
The study's results will provide valuable information about the nutritional intake and status of pregnant women who follow a strict plant-based diet compared to those who follow an omnivorous diet during pregnancy. It will also examine the impact of these diets on the health of both the mother and fetus. This information can be used in developing and improving guidelines on diet in pregnancy and may contribute to the health of pregnant women and their newborn future children in the future.
- Being tested
- Daily nutritional intake
- Keywords
- vegan diet, pregnancy, vitamin b12, omnivorous, nutrition
- Medical subject headings
- Vitamin B 12 Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daily nutritional intakeOther
Nutritional intake with a focus on vitamin B12, but also other micronutrients and macronutrients
| Study group | Role | What they receive |
|---|---|---|
| Vegan | Pregnant women with a strict plant-based diet Receives: Other: Daily nutritional intake | |
| Omnivorous | Pregnant women with an omnivorous diet. Receives: Other: Daily nutritional intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin B12 intake in mcg/day
Participants will fill out a three-day food diary in an app. The vitamin B12 intake will be extracted from this.
Measured: Participants will fill out the food diary between 27 and 30 weeks of pregnancy
Secondary outcomes (6)
Nutritional intake
Participants will fill out a three-day food diary in an app. The intake of micronutrients and macronutrients will be extracted from this app and displayed as a percentage of the daily recommended nutritional intake.
Measured: Participants will fill out the food diary between 27 and 30 weeks of pregnancy
Plasma vitamin B12
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10 milliliter (mL) of additional blood will be sampled per participant during this blood withdrawal. Plasma vitamin B12 will be shown in pmol/L.
Measured: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma vitamin D
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10mL of additional blood will be sampled per participant during this blood withdrawal. Plasma vitamin D will be shown in nmol/L.
Measured: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma ferritin
Obtaining blood samples from pregnant women for hemoglobin testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study. For study purposes, 10mL of additional blood will be sampled per participant during this blood withdrawal. Plasma ferritin will be shown in µg/L.
Measured: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma hemoglobin
Obtaining blood samples from pregnant women for hemoglobin (mmol/L) testing is a routine part of clinical practice between 27 and 30 weeks of pregnancy, and not specifically for this study.
Measured: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Maternal and fetal outcomes
Participants will fill out a questionnaire after the delivery of the baby with questions about: gestational age at delivery, gestational diabetes, pregnancy-induced hypertension, pre-eclampsia, gestational weight gain, birthweight
Measured: Participants will fill in the questionnaire between 6 weeks (min) and 6 months (max) postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitamin B 12 DeficiencyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liesbeth Scheepers, Dr., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046703
- Sponsor's protocol ID
- NL84796.068.23
- Status last verified
- Oct 2023
- First submitted
- 29 Aug 2023
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diet Quality of Pregnant Women With a Strict Plant-based Diet Versus an Omnivorous Diet: a Focus on Vitamin B12 Intake and Other Nutritional and Pregnancy-related Outcomes
- ClinicalTrials.gov ID
- NCT06046703
- Acronym / sponsor ID
- NL84796.068.23
- Keywords
- vegan diet, pregnancy, vitamin b12, omnivorous, nutrition
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 21 Sep 2023 (actual)
- 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 goal of this observational study is to compare the nutritional intake among pregnant women with a strict plant-based diet versus an omnivorous diet.
The main aim is to compare vitamin B12 intake.
Participants will be asked to:
- fill out a health questionnaire
- fill out a three-day food diary
- undergo blood sampling Researchers will compare pregnant women with a strict plant-based diet and pregnant women with an omnivorous diet to see if their nutritional intake is comparable.
Detailed description
The number of people adhering to a strict plant-based diet is increasing globally. Adequate maternal nutrition during pregnancy is essential for fetal development, as deficiencies in macro- and micronutrients can cause maternal and neonatal complications. Nutrition can play a role in developing pre-eclampsia, premature birth, and intra-uterine growth restriction. Although there is evidence of nutrient deficiencies in people who follow a strict plant-based diet and the significance of maternal diet for both maternal and fetal outcomes, there has been limited research on the nutritional intake and outcomes of pregnant women on a strict plant-based diet. Additionally, to the best of our knowledge, very limited research has been published on the incidence of pregnancy-induced hypertension, pre-eclampsia, gestational diabetes, or pre-term birth in women on a strict plant-based diet. The relation between these outcomes and nutritional intake/status is also unknown in this specific group of women, even though the number of people with a strict plant-based diet is increasing. The only two studies that studied pregnancy-related outcomes in women on a strict plant-based diet were performed in Israel and were not powered to show statistical differences between a strict plant-based diet and obstetrical outcomes. Additionally, the dietary intake in Israel differs from other parts of the world. Thus, it is impossible to ascertain if the results also apply to a population with a distinct diet. Recently, the Royal Dutch Organization of Midwives (Koninklijke Nederlandse Organisatie van Verloskundigen, KNOV) published 'the guide for vegetarian and vegan diet in pregnancy .' They acknowledge the limited availability of scientific research concerning the strict plant-based diet in pregnancy and the non-existence of data on Dutch pregnant women. They recommend performing additional blood tests for vitamin B12 and D in case of possible nutrition deficiencies in this group of pregnant women. A significantly lower ferritin level is also described in pregnant women on a strict plant-based diet. In conclusion, even though the nutritional intake during pregnancy is vital for both mother and child, the nutritional intake amongst Dutch women on a strict plant-based diet during pregnancy is unknown. Previously published results from Israeli women do not apply to the Dutch population, as nutritional intake differs between countries. The recently published KNOV guide suggests checking vitamin blood levels during pregnancy. To advise and update guidelines for Dutch women on a strict plant-based diet during pregnancy, additional research on nutritional intake and the nutritional status of Dutch women on a strict plant-based diet and to compare this with nutritional status of omnivorous pregnant women is crucial.
The participant will complete a health-related questionnaire. The estimated time required to complete the questionnaire is approximately 10 minutes. Additionally, between 27 and 30 weeks of pregnancy, participants will fill out a three-day food diary. It is estimated that the questionnaire will take approximately 30 minutes to complete each day. Finally, the participants must complete a questionnaire following the baby's delivery. This questionnaire will cover various aspects, such as the pregnancy, delivery, and blood results obtained during pregnancy. The estimated time required to complete the questionnaire is approximately 15 minutes.
During the blood sampling, 10 ml of blood will be collected using an evacuated tube system through venepuncture. Taking blood samples is a routine part of clinical practice, not solely for this study. Pregnant women typically undergo venipuncture between 27 and 30 weeks as part of regular obstetrical care.
The study's results will provide valuable information about the nutritional intake and status of pregnant women who follow a strict plant-based diet compared to those who follow an omnivorous diet during pregnancy. It will also examine the impact of these diets on the health of both the mother and fetus. This information can be used in developing and improving guidelines on diet in pregnancy and may contribute to the health of pregnant women and their newborn future children in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vegan | – | Other: Daily nutritional intakePregnant women with a strict plant-based diet |
| Omnivorous | – | Other: Daily nutritional intakePregnant women with an omnivorous diet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women from the Netherlands
Key inclusion criteria (4 listed)
- Before 27 weeks of pregnancy
- Age >18 years
- Strict plant-based diet (vegan diet), defined as a diet without ingestion of animal products (i.e., intake less than once a month during) the entire pregnancy or omnivorous diet, defined as a diet that includes meat
- Willing and able to give written informed consent and to understand, participate and comply with the research project requirements
Key exclusion criteria (5 listed)
- Food allergy that influences the nutritional intake, e.g., milk allergy, celiac disease, and lactose intolerance
- Medical history of gastrointestinal diseases such as Crohn's disease and other diseases associated with vitamin B12 deficiencies such as (pre-existing) diabetes.
- Medical history of abdominal surgery interfering with nutrient uptake, such as gastric bypass and intestinal resections
- Pre-existing cardio-vascular diseases or auto-immune diseases
- Insufficient understanding of the Dutch language
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 |
|---|---|---|
| Daily nutritional intakeNutritional intake with a focus on vitamin B12, but also other micronutrients and macronutrients | Other | Omnivorous, Vegan |
Primary outcome
Vitamin B12 intake in mcg/day
Time frame: Participants will fill out the food diary between 27 and 30 weeks of pregnancy
Participants will fill out a three-day food diary in an app. The vitamin B12 intake will be extracted from this.
6 secondary outcomes
Nutritional intake
Time frame: Participants will fill out the food diary between 27 and 30 weeks of pregnancy
Plasma vitamin B12
Time frame: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma vitamin D
Time frame: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma ferritin
Time frame: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Plasma hemoglobin
Time frame: Participants will time the blood draw within 2 weeks after filling out the food diary between 27 en 30 weeks of pregnancy
Maternal and fetal outcomes
Time frame: Participants will fill in the questionnaire between 6 weeks (min) and 6 months (max) postpartum
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 13 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Liesbeth Scheepers, Dr. principal investigator
Maastricht University Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Vitamin B 12 Deficiency and Pregnancy, run by Maastricht University Medical Center.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Deidre Meulenbroeks, Dr. (0031433874768, voedingzwangerschap@mumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vitamin B12 intake in mcg/day (time frame: Participants will fill out the food diary between 27 and 30 weeks of pregnancy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2024.