Vitamin D DeficiencyPhase 4NCT01112891
Vitamin D in Pregnancy and Lactation
A Phase 4 study testing Vitamin D and Vitamin D3 in people with Vitamin D Deficiency, run by University of British Columbia at 1 site in Canada.
Trial summary
Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- Vitamin D and Vitamin D3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Feb 2013
- 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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between 18-42 years of age
- within 18 plus/minus 3 weeks gestation
- planning to breastfeed their infant
- a singleton pregnancy
Who cannot join
- Any co-morbid condition such pre-gestational diabetes, TB, cardiac or renal disease, HIV/AIDS, chronic hypertension, inflammatory bowel disease, autoimmune disease, liver disease, or epilepsy; conditions associated with vitamin D malabsorption: celiac disease, gastric bypass;
- History of previous adverse pregnancy outcome [preterm delivery <37; weeks GA, stillbirth, severe pre-eclampsia, eclampsia, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count)];
- Women will also be ineligible if they are taking more than 10 µg day supplemental vitamin D or drugs known to interfere with vitamin D metabolism (i.e corticosteroids).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Dose-response Study Throughout Pregnancy and Lactation
Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD>75nmol/L.
Read the detailed description
Purpose \& Hypothesis: This project aims to determine maternal and infant responses vitamin D supplementation in pregnancy and lactation. It is hypothesized that the current AI of 5 μg of vitamin D will be inadequate for women and their infants in Canada to achieve optimal 25OHD concentrations (> 75nmol/L).
Methods: Healthy pregnant women between 18-42 years of age without history of pregnancy complications will be recruited for a double-blind, randomized, controlled trial where they will receive one of three different dosages of vitamin D (10, 25 and 50ug/day) as part of a standard prenatal vitamin. The study at 18 plus/minus 3 weeks gestation and will carry on throughout pregnancy and lactation. Mother and infant vitamin D levels in breast milk and blood will be measured at regular intervals. Skin colour will be measured via light reflectometry. Bone biomarkers such as plasma osteocalcin and urinary n-telopeptide will be assessed. Dietary vitamin D intake and sun exposure will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values.
Expected Results \& Conclusions: It is expected that greater vitamin D intakes (25, 50ug/day) will be necessary to raise maternal and infant serum concentrations to 25OHD>75nmol/L to avoid infant supplementation. This data will aid policy makers, mothers and healthcare workers in recommended and appropriate vitamin D dosage throughout pregnancy and lactation.
- Conditions
- Vitamin D Deficiency
- Being tested
- Vitamin D, Vitamin D3
- Keywords
- Vitamin D, Infant, Lactation, Dose-Response
- 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.
Vitamin DDrug
10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
Vitamin D3Drug
25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
Vitamin DDrug
50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Vitamin D |
| 2 | Experimental | Not described Receives: Drug: Vitamin D3 |
| 3 | Experimental | Not described Receives: Drug: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
25(OH)D Plasma Concentrations
Measured: 18 weeks gestation for mother
25(OH)D Plasma Concentrations
Measured: 28 weeks gestation for mother
25(OH)D Plasma Concentrations
Measured: 36 weeks gestation for mother
25(OH)D Plasma Concentrations
Measured: 16 weeks post-partum for mother & infant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionAug 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vitamin D DeficiencyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Tim Green, Dr., Principal investigator, University of British ColumbiaSheila M. Innis, Dr., Study director, University of British ColumbiaMichael R. Lyon, MD, Study director, University of British ColumbiaAntonia W. Shand, Dr, Study director, University of British ColumbiaPeter von Dadelszen, MD, Study director, University of British ColumbiaRuss Freisen, MSc, Study chair, University of British ColumbiaKaitlin March, Study chair, University of British ColumbiaTina Li, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112891
- Sponsor's protocol ID
- H09-01261
- Other IDs
- F08-03892
- Status last verified
- Dec 2014
- First submitted
- 27 Apr 2010
- Last updated
- 16 Dec 2014
- 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 39077939Stamm RA, March KM, Karakochuk CD, Gray AR, Brown RC, Green TJ, Houghton LA. Lactating Canadian Women Consuming 1000 microg Folic Acid Daily Have High Circulating Serum Folic Acid Above a Threshold Concentration of Serum Total Folate. J Nutr. 2018 Jul 1;148(7):1103-1108. doi: 10.1093/jn/nxy070.
PubMed 29901753March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D(3) supplementation at 50 mug/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. Am J Clin Nutr. 2015 Aug;102(2):402-10. doi: 10.3945/ajcn.114.106385. Epub 2015 Jul 8.
PubMed 26156737
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Dose-response Study Throughout Pregnancy and Lactation
- ClinicalTrials.gov ID
- NCT01112891
- Acronym / sponsor ID
- H09-01261
- Conditions
- Vitamin D Deficiency
- Keywords
- Vitamin D, Infant, Lactation, Dose-Response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Mar 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 29 Apr 2010 (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.
Background: Vitamin D is vital throughout pregnancy and lactation for both maternal and infant health. Health Canada recommends women take the AI of 5ug/day of vitamin D during pregnancy, however, it is unknown how much vitamin D is necessary to ensure both mother and baby reach a vitamin D serum concentration of 25OHD>75nmol/L.
Detailed description
Purpose \& Hypothesis: This project aims to determine maternal and infant responses vitamin D supplementation in pregnancy and lactation. It is hypothesized that the current AI of 5 μg of vitamin D will be inadequate for women and their infants in Canada to achieve optimal 25OHD concentrations (> 75nmol/L).
Methods: Healthy pregnant women between 18-42 years of age without history of pregnancy complications will be recruited for a double-blind, randomized, controlled trial where they will receive one of three different dosages of vitamin D (10, 25 and 50ug/day) as part of a standard prenatal vitamin. The study at 18 plus/minus 3 weeks gestation and will carry on throughout pregnancy and lactation. Mother and infant vitamin D levels in breast milk and blood will be measured at regular intervals. Skin colour will be measured via light reflectometry. Bone biomarkers such as plasma osteocalcin and urinary n-telopeptide will be assessed. Dietary vitamin D intake and sun exposure will be estimated using a food frequency and lifestyle questionnaire. Data will be analyzed using multiple regression analysis controlling for baseline values.
Expected Results \& Conclusions: It is expected that greater vitamin D intakes (25, 50ug/day) will be necessary to raise maternal and infant serum concentrations to 25OHD>75nmol/L to avoid infant supplementation. This data will aid policy makers, mothers and healthcare workers in recommended and appropriate vitamin D dosage throughout pregnancy and lactation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Vitamin D |
| 2 | Experimental | Drug: Vitamin D3 |
| 3 | Experimental | Drug: Vitamin D |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Women between 18-42 years of age
- within 18 plus/minus 3 weeks gestation
- planning to breastfeed their infant
- a singleton pregnancy
Key exclusion criteria (3 listed)
- Any co-morbid condition such pre-gestational diabetes, TB, cardiac or renal disease, HIV/AIDS, chronic hypertension, inflammatory bowel disease, autoimmune disease, liver disease, or epilepsy; conditions associated with vitamin D malabsorption: celiac disease, gastric bypass;
- History of previous adverse pregnancy outcome [preterm delivery <37; weeks GA, stillbirth, severe pre-eclampsia, eclampsia, HELLP syndrome (hemolytic anemia, elevated liver enzymes, and low platelet count)];
- Women will also be ineligible if they are taking more than 10 µg day supplemental vitamin D or drugs known to interfere with vitamin D metabolism (i.e corticosteroids).
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 |
|---|---|---|
| Vitamin D10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. | Drug | 1 |
| Vitamin D325 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. | Drug | 2 |
| Vitamin D50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum. | Drug | 3 |
Primary outcome
25(OH)D Plasma Concentrations
Time frame: 18 weeks gestation for mother
25(OH)D Plasma Concentrations
Time frame: 28 weeks gestation for mother
25(OH)D Plasma Concentrations
Time frame: 36 weeks gestation for mother
25(OH)D Plasma Concentrations
Time frame: 16 weeks post-partum for mother & infant
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 16 Dec 2014.
- 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.
- Derived from this study: PubMed 29901753Stamm RA, March KM, Karakochuk CD, Gray AR, Brown RC, Green TJ, Houghton LA. Lactating Canadian Women Consuming 1000 microg Folic Acid Daily Have High Circulating Serum Folic Acid Above a Threshold Concentration of Serum Total Folate. J Nutr. 2018 Jul 1;148(7):1103-1108. doi: 10.1093/jn/nxy070.
- Derived from this study: PubMed 26156737March KM, Chen NN, Karakochuk CD, Shand AW, Innis SM, von Dadelszen P, Barr SI, Lyon MR, Whiting SJ, Weiler HA, Green TJ. Maternal vitamin D(3) supplementation at 50 mug/d protects against low serum 25-hydroxyvitamin D in infants at 8 wk of age: a randomized controlled trial of 3 doses of vitamin D beginning in gestation and continued in lactation. Am J Clin Nutr. 2015 Aug;102(2):402-10. doi: 10.3945/ajcn.114.106385. Epub 2015 Jul 8.
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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.
Tim Green, Dr. principal investigator
University of British Columbia
Sheila M. Innis, Dr. study director
University of British Columbia
Michael R. Lyon, MD study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vitamin D and Vitamin D3 in people with Vitamin D Deficiency, run by University of British Columbia at 1 site in Canada.
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 3 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 16 Dec 2014. 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 Canada. 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.
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?
25(OH)D Plasma Concentrations (time frame: 18 weeks gestation for mother). The study lists 4 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 NCT01112891, which also lists 3 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 16 Dec 2014.