Vitamin D DeficiencyPhase 4MAVIDNCT01506557
Vitamin D Supplementation of Lactating Mothers
A Phase 4 study testing cholecalciferol in people with Vitamin D Deficiency, run by Children's Memorial Health Institute, Poland at 5 sites in Poland.
Trial summary
The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 174 participants
- Where
- 5 sitesPoland
- Study dates
- Mar 2011to Nov 2012
- Phase
- Phase 4
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem
Who cannot join
- Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
- Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Poland5 sites
Public Hospital
Otwock, Warsaw, 05-400
Anna Mazowiecka Hospital, Warsaw Medical University
Warsaw, 00-315
Gynecological and Obstetric Hospital
Warsaw, 02-544
The Children's Memorial Health Institute
Warsaw, 04-730
Międzyleski Hospital,
Warsaw, 04-749
About this study
Official title: Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.
The investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.
The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.
Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.
- Conditions
- Vitamin D Deficiency
- Being tested
- cholecalciferol, placebo
- Keywords
- vitamin D, vitamin D deficiency, breastfeeding, body composition, bone mineral content
- Medical subject headings
- Vitamin D Deficiency, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDietary supplement
Also called vit D
dose 800 IU/day for 6 month
placeboDietary supplement
oil capsules
| Study group | Role | What they receive |
|---|---|---|
| choecalciferol | Experimental | Not described Receives: Dietary Supplement: cholecalciferol |
| placebo | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum 25-hydroxyvitamin D concentration,
Measured: 3 time poits up to 6 months (0-3-6 months)
Secondary outcomes (6)
body composition measured by dual x-ray densitometry
Measured: 3 time points up to 6 months (0-3-6months)
serum calcium
Measured: 2 time poits up to 6 months ( 3-6 months)
calciuria (Urinary calcium and creatinine - UCa/crea)
Measured: 2 time poits up to 6 months ( 3-6 months)
iPTH
Measured: 3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D deficiency (25OHD<20ng/ml)
Measured: 3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)
Measured: 3 time poits up to 6 months (0-3-6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2012 (estimated)
- Study startMar 2011
- Primary completionOct 2012
- Study completionNov 2012
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 Vitamin D 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Memorial Health Institute, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Nutricia Research Fundation
- Responsible party
- Principal investigator, Justyna Czech-Kowalska, Children's Memorial Health Institute, Poland
- Investigators
- Justyna Czech-Kowalska, MD, PhD, Principal investigator, The Children's Memorial Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01506557
- Sponsor's protocol ID
- 763/10
- Acronym
- MAVID
- Status last verified
- Jul 2013
- First submitted
- 11 May 2011
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Sep 18;9(9):e107708. doi: 10.1371/journal.pone.0107708. eCollection 2014.
PubMed 25232839
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vitamin D Supplementation During Lactation on Vitamin D Status, Bone Mineralisation and Body Composition of Mother and Their Exclusively Breastfed Infants.
- ClinicalTrials.gov ID
- NCT01506557
- Acronym / sponsor ID
- MAVID / 763/10
- Conditions
- Vitamin D Deficiency
- Keywords
- vitamin D, vitamin D deficiency, breastfeeding, body composition, bone mineral content
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Children's Memorial Health Institute, PolandUniversity, hospital or other
- Collaborators
- Nutricia Research Fundation
- Study start
- Mar 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 10 Jan 2012 (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 investigators would like to test the hypothesis that maternal vitamin D supplementation during lactation in dose 1200IU/d (400IU from multivitamins + 800 IU cholecalciferol) is more effective than 400IU/d (400IU from multivitamins + placebo)to built appropriate maternal vitamin D status and could be beneficial for maternal and infants bone mineralization and body composition (proper proportion of muscle and fat tissues in body weight) and is safe for both.
The investigators also want to confirm that vitamin D supplementation of exclusively breastfed infants in dose 400IU/d is adequate to build appropriate vitamin D status independently of mother's vitamin D supplementation up to 1200 ID/d.
Additionally the investigators hypothesize that because of changes in lifestyle there will be no substantial seasonal differences in vitamin D status of pregnant women at the delivery and their newborn infants.
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 |
|---|---|---|
| choecalciferol | Experimental | Dietary Supplement: cholecalciferol |
| placebo | Placebo comparator | Dietary Supplement: placebo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy women without major medical problem delivered at term and planning breastfeeding for next six months delivering term, single, infants with birth weight appropriate for gestational age without major health problem
Key exclusion criteria (2 listed)
- Maternal endocrine disorders, disturbed calcium- phosphorus homeostasis, anticonvulsant treatment.
- Infants renal, hepatic insufficiency, endocrine disorders, congenital malformations, anticonvulsant treatment.
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 |
|---|---|---|
| cholecalciferolAlso: vit Ddose 800 IU/day for 6 month | Dietary supplement | choecalciferol |
| placebooil capsules | Dietary supplement | placebo |
Primary outcome
serum 25-hydroxyvitamin D concentration,
Time frame: 3 time poits up to 6 months (0-3-6 months)
6 secondary outcomes
body composition measured by dual x-ray densitometry
Time frame: 3 time points up to 6 months (0-3-6months)
serum calcium
Time frame: 2 time poits up to 6 months ( 3-6 months)
calciuria (Urinary calcium and creatinine - UCa/crea)
Time frame: 2 time poits up to 6 months ( 3-6 months)
iPTH
Time frame: 3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D deficiency (25OHD<20ng/ml)
Time frame: 3 time poits up to 6 months (0-3-6 months)
Prevalence of vitamin D sufficiency (25OHD>30ng/ml)
Time frame: 3 time poits up to 6 months (0-3-6 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Derived from this study: PubMed 25232839Czech-Kowalska J, Latka-Grot J, Bulsiewicz D, Jaworski M, Pludowski P, Wygledowska G, Chazan B, Pawlus B, Zochowska A, Borszewska-Kornacka MK, Karczmarewicz E, Czekuc-Kryskiewicz E, Dobrzanska A. Impact of vitamin D supplementation during lactation on vitamin D status and body composition of mother-infant pairs: a MAVID randomized controlled trial. PLoS One. 2014 Sep 18;9(9):e107708. doi: 10.1371/journal.pone.0107708. eCollection 2014.
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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.
Justyna Czech-Kowalska, MD, PhD principal investigator
The Children's Memorial Health Institute
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing cholecalciferol in people with Vitamin D Deficiency, run by Children's Memorial Health Institute, Poland at 5 sites in Poland.
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 1 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: finished, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Poland. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
serum 25-hydroxyvitamin D concentration, (time frame: 3 time poits up to 6 months (0-3-6 months)). 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 NCT01506557, 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 23 Jul 2013.