Birth WeightGravitaNCT01038453
Effects of Vitamin D Supplement Before and During Pregnancy on Birth Weight
A study testing Cholecalciferol 35 µg per day and Cholecalciferol (Vitamin D3) 70 µg in people with Birth Weight and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
Trial summary
The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation. Read more about this study
- Who is it for?
- Ages 20 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Birth Weight, Vitamin D Deficiency, Pregnancy
- What is being tested?
- Cholecalciferol 35 µg per day and Cholecalciferol (Vitamin D3) 70 µg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteDenmark
- Study dates
- Dec 2009to Dec 2011
- Phase
- Interventional
- 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 20 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- P-OH25-vitamin D < 50 nmol/l
- Woman age 30-35 years
- In good general health
Who cannot join
- Infertility
- Intake of 400 IU or more Vitamin D/day
- Cancer
- Alcohol or drug abuse
- Calciummetabolic disturbances
- Spontaneous abortion within last 6 month
Trial locations and contacts
1 site in 1 country.
Lars Rejnmark, MD, PhD, DrMed contact
Denmark1 site, 1 recruiting
- Recruiting
University of Aarhus, Aarhus Universityhospital
Aarhus
Gitte Bloch Rasmussen, MD, +45 89 49 76 81, gittebr@ki.au.dk
Lars Rjenmark, MD,PhD,DrMed, rejnmark@post6.tele.dk
About this study
Official title: Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation
The purpose of this study is to determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.
- Conditions
- Birth Weight, Vitamin D Deficiency, Pregnancy
- Being tested
- Cholecalciferol 35 µg per day, placebo tablet, Cholecalciferol (Vitamin D3) 70 µg
- Medical subject headings
- Birth Weight, Vitamin D Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cholecalciferol 35 µg per dayDietary supplement
Cholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day.
In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.
placebo tabletOther
placebo 2 tablet, once a day,
Cholecalciferol (Vitamin D3) 70 µgDietary supplement
Cholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day.
In total 2 tablets per day per participant from Baseline to 16 weeks after delivery.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol (Vitamin D3) 35 µg | Active comparator | Dietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day Receives: Dietary Supplement: Cholecalciferol 35 µg per day |
| Cholecalciferol (Vitamin D3) 70 µg | Active comparator | Dietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day Receives: Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µg |
| placebo | Placebo comparator | Not described Receives: Other: placebo tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Weight
Measured: 0-24 hours after delivery of the child
Secondary outcomes (4)
Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Measured: Day 1 to 4 months after delivery.
Infections of the newborn
Measured: Day 1 of the child to 16 weeks after birth.
Growth of the newborn measured by weight, crown-heel length and head circumference
Measured: Day 1 of the child to 16 weeks after birth
Time to accomplish pregnancy
Measured: 0-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Birth WeightStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gitte Bloch Rasmussen, MD, Principal investigator, Aarhus University HospitalLars Rejnmark, MD, PhD, Drmed., Study director, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038453
- Sponsor's protocol ID
- M-20090097
- Acronym
- Gravita
- Status last verified
- Nov 2011
- First submitted
- 18 Dec 2009
- Last updated
- 4 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
PubMed 39077939
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Vitamin D Supplement Before and During Pregnancy on Complications, Birth Weight and Bone Mineral Density During Lactation
- ClinicalTrials.gov ID
- NCT01038453
- Acronym / sponsor ID
- Gravita / M-20090097
- Conditions
- Birth Weight, Vitamin D Deficiency, Pregnancy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 24 Dec 2009 (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 determine whether a daily supplement of vitamin D, taking before and during pregnancy, effects child birth weight, pre- and postpartum complication and bone mineral density during lactation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol (Vitamin D3) 35 µg | Active comparator | Dietary Supplement: Cholecalciferol 35 µg per dayDietary Supplement: Cholecalciferol (Vitamin D3) 35 µg per day |
| Cholecalciferol (Vitamin D3) 70 µg | Active comparator | Dietary Supplement: Cholecalciferol (Vitamin D3) 70 µgDietary supplement: Cholecalciferol (Vitamin D3) 70 µg per day |
| placebo | Placebo comparator | Other: placebo tablet |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- P-OH25-vitamin D < 50 nmol/l
- Woman age 30-35 years
- In good general health
Key exclusion criteria (6 listed)
- Infertility
- Intake of 400 IU or more Vitamin D/day
- Cancer
- Alcohol or drug abuse
- Calciummetabolic disturbances
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 |
|---|---|---|
| Cholecalciferol 35 µg per dayCholecalciferol (Vitamin D3) oral 1 tablet 35 µg per day. Placebo oral 1 tablet per day. In total 35 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery. | Dietary supplement | Cholecalciferol (Vitamin D3) 35 µg |
| placebo tabletplacebo 2 tablet, once a day, | Other | placebo |
| Cholecalciferol (Vitamin D3) 70 µgCholecalciferol (Vitamin D3) oral 2 tablets each containing 35 µg. In total 70 µg per day. In total 2 tablets per day per participant from Baseline to 16 weeks after delivery. | Dietary supplement | Cholecalciferol (Vitamin D3) 70 µg |
Primary outcome
Birth Weight
Time frame: 0-24 hours after delivery of the child
4 secondary outcomes
Post-partum effects of vitamin D supplement on maternal bone mineral density (BMD).
Time frame: Day 1 to 4 months after delivery.
Infections of the newborn
Time frame: Day 1 of the child to 16 weeks after birth.
Growth of the newborn measured by weight, crown-heel length and head circumference
Time frame: Day 1 of the child to 16 weeks after birth
Time to accomplish pregnancy
Time frame: 0-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2011.
- Derived from this study: PubMed 39077939Palacios C, Kostiuk LL, Cuthbert A, Weeks J. Vitamin D supplementation for women during pregnancy. Cochrane Database Syst Rev. 2024 Jul 30;7(7):CD008873. doi: 10.1002/14651858.CD008873.pub5.
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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.
Lars Rejnmark, MD, PhD, DrMed contact
Gitte Bloch Rasmussen, MD principal investigator
Aarhus University Hospital
Lars Rejnmark, MD, PhD, Drmed. study director
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cholecalciferol 35 µg per day and Cholecalciferol (Vitamin D3) 70 µg in people with Birth Weight and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
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 3 inclusion and 6 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 4 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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. Some participants in this study may receive a placebo. 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 Gitte Bloch Rasmussen, MD (+45 89 4976 81, gittebr@ki.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth Weight (time frame: 0-24 hours after delivery of the child). 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 NCT01038453, which also lists 1 linked publication.
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 4 Nov 2011.