GrowthNCT05616117
Next-generation Effects of Vitamin D Supplementation in Pregnancy
An observational study of Growth and Vitamin D Supplementation, run by University of Aarhus.
Trial summary
Vitamin D deficiency is common among pregnant women, despite daily vitamin D supplements. This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Read more about this study
- Who is it for?
- Ages Up to 15 monthsHealthy volunteers can take part
- Conditions the study is for
- Growth, Vitamin D Supplementation, Immune System Diseases
- What is being tested?
- Intrauterine 90µg D-vitamin and Intrauterine 10µg D-vitamin
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Nov 2022to Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 15 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children born to mothers participated in our previous RCT (NCT04291313)
Who may be able to join
- Born by mother from our previous RCT (NCT04291313)
- All with parental authority have given consent for inclusion
Who cannot join
- Mother with compliance <80% to study drug
- Mother has denied further contact in this follow-up study
Trial locations and contacts
No sites are listed yet.
About this study
Vitamin D deficiency is common among pregnant women, despite daily vitamin D supplements. This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after one year, questionnaires and clinical 1-year examination will be performed on the children.
Read the detailed description
Vitamin D deficiency is common among Danish pregnant women, although most pregnant women adhere to guidelines of a daily supplement of 10 µg vitamin D. Vitamin D deficiency increases the risk of complications in the pregnancy e.g., preeclampsia, gestational diabetes mellitus and fetal growth retardation. Several studies indicate that the offspring has an increased risk of immune diseases e.g., asthma and autoimmune related diseases e.g., multiple sclerosis if the mother had vitamin D deficiency during the pregnancy. It is well known that vitamin D affects the immune system, which raises the question of the effects of vitamin D supplements and which doses to give optimally.
This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg D3 affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after 1 year, questionnaires and clinical 1-year examination will be performed on the children. The hypothesis is that increased vitamin D supplementation in pregnancy improves fetal development including the offspring's immune system and the developing brain. The effects of vitamin D supplementation will strengthen the offspring's overall health at birth and during their first year of life. Hopefully, this can, in the future, be part of a guideline to which dose of vitamin D is recommended for Danish pregnant women.
- Being tested
- Intrauterine 90µg D-vitamin, Intrauterine 10µg D-vitamin
- Medical subject headings
- Immune System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrauterine 90µg D-vitaminOther
Children of mothers who received 90 µg vitamin D3 daily during pregnancy:10 µg from a standard prenatal multivitamin + an additional supplement containing 80µg of vitamin D3
Intrauterine 10µg D-vitaminOther
Children of mothers who received 10 µg vitamin D3 daily during pregnancy, which is the dose in a standard prenatal multivitamin and the dose currently recommended by the Danish Health Authorities to all pregnant women. They will receive a prenatal vitamin containing 10µg of vitamin D + a placebo supplement.
| Study group | Role | What they receive |
|---|---|---|
| High-dose intrauterine D3-vitamin | Children of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery. Receives: Other: Intrauterine 90µg D-vitamin | |
| Low-dose intrauterine D3-vitamin | Children of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery Receives: Other: Intrauterine 10µg D-vitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth of child
The growth from birth to the clinical examination at 11-13 month of age
Measured: From birth to 11-13 month of age
Immune cell function
The immune cell function at birth and at 11-13 month of age.
Measured: From birth to 11-13 month of age
Secondary outcomes (6)
Well-being and developmental scores
ASQ-3 scores and parent-reported well-being of the children at 11-13 month of age.
Measured: At birth and at 11-13 month of age
Hospital contact
Number of hospital contacts during the first year
Measured: At birth to 11-13 month of age
Parent reported infections
Number of infections during the first year of life
Measured: At birth to 11-13 month of age
Colic
Does the child have colic
Measured: At birth to 11-13 month of age
Medicine use
Parent reported use of medicine, incl. astma-medicine and movicol.
Measured: At birth to 11-13 month of age
Scanning of the anterior fontanelle
Ultrasound-scan of the anterior fontanelle
Measured: At 11-13 month of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2022
- Study startNov 2022 (estimated)
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GrowthStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pinar Bor, MD, PhD, Principal investigator, Department of Obstetrics and Gynaecology, Regional Hospital Randers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05616117
- Sponsor's protocol ID
- 01092022
- Status last verified
- Oct 2022
- First submitted
- 7 Nov 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-generation Effects of Vitamin D Supplementation in Pregnancy
- ClinicalTrials.gov ID
- NCT05616117
- Acronym / sponsor ID
- 01092022
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Nov 2022 (estimated)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 15 Nov 2022 (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.
Vitamin D deficiency is common among pregnant women, despite daily vitamin D supplements. This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after one year, questionnaires and clinical 1-year examination will be performed on the children.
Detailed description
Vitamin D deficiency is common among Danish pregnant women, although most pregnant women adhere to guidelines of a daily supplement of 10 µg vitamin D. Vitamin D deficiency increases the risk of complications in the pregnancy e.g., preeclampsia, gestational diabetes mellitus and fetal growth retardation. Several studies indicate that the offspring has an increased risk of immune diseases e.g., asthma and autoimmune related diseases e.g., multiple sclerosis if the mother had vitamin D deficiency during the pregnancy. It is well known that vitamin D affects the immune system, which raises the question of the effects of vitamin D supplements and which doses to give optimally.
This study aims to investigate if maternal vitamin D intake of 90 vs 10 µg D3 affects the overall health, growth, and immune system of the offspring at birth and after 1 year. Blood samples at birth and after 1 year, questionnaires and clinical 1-year examination will be performed on the children. The hypothesis is that increased vitamin D supplementation in pregnancy improves fetal development including the offspring's immune system and the developing brain. The effects of vitamin D supplementation will strengthen the offspring's overall health at birth and during their first year of life. Hopefully, this can, in the future, be part of a guideline to which dose of vitamin D is recommended for Danish pregnant women.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-dose intrauterine D3-vitamin | – | Other: Intrauterine 90µg D-vitaminChildren of mothers who received 90 µg vitamin D3 daily during pregnancy from 12 weeks to delivery. |
| Low-dose intrauterine D3-vitamin | – | Other: Intrauterine 10µg D-vitaminChildren of mothers who received 10 µg vitamin D3 daily during pregnancy from 12 weeks to delivery |
Who may qualify
- Ages
- Up to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children born to mothers participated in our previous RCT (NCT04291313)
Key inclusion criteria (2 listed)
- Born by mother from our previous RCT (NCT04291313)
- All with parental authority have given consent for inclusion
Key exclusion criteria (2 listed)
- Mother with compliance <80% to study drug
- Mother has denied further contact in this follow-up study
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 |
|---|---|---|
| Intrauterine 90µg D-vitaminChildren of mothers who received 90 µg vitamin D3 daily during pregnancy:10 µg from a standard prenatal multivitamin + an additional supplement containing 80µg of vitamin D3 | Other | High-dose intrauterine D3-vitamin |
| Intrauterine 10µg D-vitaminChildren of mothers who received 10 µg vitamin D3 daily during pregnancy, which is the dose in a standard prenatal multivitamin and the dose currently recommended by the Danish Health Authorities to all pregnant women. They will receive a prenatal vitamin containing 10µg of vitamin D + a placebo supplement. | Other | Low-dose intrauterine D3-vitamin |
Primary outcome
Growth of child
Time frame: From birth to 11-13 month of age
The growth from birth to the clinical examination at 11-13 month of age
Immune cell function
Time frame: From birth to 11-13 month of age
The immune cell function at birth and at 11-13 month of age.
6 secondary outcomes
Well-being and developmental scores
Time frame: At birth and at 11-13 month of age
Hospital contact
Time frame: At birth to 11-13 month of age
Parent reported infections
Time frame: At birth to 11-13 month of age
Colic
Time frame: At birth to 11-13 month of age
Medicine use
Time frame: At birth to 11-13 month of age
Scanning of the anterior fontanelle
Time frame: At 11-13 month of age.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- 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. This study is not recruiting at the moment.
Pinar Bor, MD, PhD principal investigator
Department of Obstetrics and Gynaecology, Regional Hospital Randers
Questions about this trial
What is this clinical trial studying?
An observational study of Growth and Vitamin D Supplementation, run by University of Aarhus.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pinar Bor, MD, PhD (+4522504767, isipinbo@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Growth of child (time frame: From birth to 11-13 month of age). 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?
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 15 Nov 2022.