Vitamin D DeficiencyPhase 3NCT00412074
Establishing the Vitamin D Requirements During Lactation
A Phase 3 study testing 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol) and 6400 IU Vitamin D3 (cholecalciferol) in people with Vitamin D Deficiency, run by Medical University of South Carolina at 2 sites in United States.
Trial summary
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency
- What is being tested?
- 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol) and 6400 IU Vitamin D3 (cholecalciferol)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2006to Oct 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Mother plans to breastfeed exclusively for at least six months
- Mother is in good health
- Infant is 35 weeks' gestation or greater
- Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).
Who cannot join
- Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
- Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
- Infant is less than 35 weeks' gestation
- Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
- Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
- Mother has history of hypercalciuria
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this study is to determine the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Read the detailed description
Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will receive placebo. On 2/5/2009, the protocol was amended and the Group B arm was dropped; infants of active subjects randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through study completion. Newly enrolled subjects after this date were randomized to Group A or Group C only.
By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.
- Conditions
- Vitamin D Deficiency
- Being tested
- 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol), 6400 IU Vitamin D3 (cholecalciferol)
- Keywords
- Breastfeeding, Vitamin D, Vitamin D deficiency
- 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.
400 IU Vitamin D3 (cholecalciferol)Drug
400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant
2400 IU Vitamin D3 (cholecalciferol)Drug
2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
6400 IU Vitamin D3 (cholecalciferol)Drug
6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant
| Study group | Role | What they receive |
|---|---|---|
| Control 400 IU vitamin D3 | Active comparator | 400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad Receives: Drug: 400 IU Vitamin D3 (cholecalciferol) |
| 2400 IU vitamin D3 (cholecalciferol) | Experimental | 2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Receives: Drug: 2400 IU Vitamin D3 (cholecalciferol) |
| 6400 IU vitamin D3 (cholecalciferol) | Experimental | 6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant Receives: Drug: 6400 IU Vitamin D3 (cholecalciferol) |
What is being measured
The primary outcome is the main question the study is designed to answer.
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
Measured: to 7 months postpartum
Secondary outcomes (2)
Maternal Health Status - Vitamin D Deficiency
Percentage of subjects with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7
Measured: to 7 months postpartum
Infant Health Status - Vitamin D Deficiency
Percentage of infants with 25-hydroxyvitamin D [25(OH)D] concentration <20 ng/mL at Visit 7
Measured: to 7 months 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 Dec 2006 (estimated)
- Study startAug 2006
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)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 Medical University of South CarolinaThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 460 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Carol Wagner, Medical University of South Carolina
- Investigators
- Bruce W. Hollis, Ph.D, Principal investigator, Medical University of South CarolinaCarol L. Wagner, MD, Principal investigator, Medical University of South CarolinaThomas C. Hulsey, Ph.D, Study chair, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412074
- Sponsor's protocol ID
- HD047511
- Other IDs
- R01HD047511
- Status last verified
- May 2018
- First submitted
- 13 Dec 2006
- Last updated
- 4 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Ramadurai S, Andrews C, Cheema S, Thomas R, Wagner CL, Sen S. Maternal Predictors of Breast Milk Plasmalogens and Associations with Infant Body Composition and Neurodevelopment. Clin Ther. 2022 Jul;44(7):998-1009. doi: 10.1016/j.clinthera.2022.06.003. Epub 2022 Jul 29.
PubMed 35909001Andrews L, Phlegar K, Baatz JE, Ebeling MD, Shary JR, Gregoski MJ, Howard CR, Hollis BW, Wagner CL. Comparison of Infant Bone Mineral Content and Density After Infant Daily Oral Vit D 400 IU Supplementation Versus Nursing Mother Oral 6,400 IU Supplementation: A Randomized Controlled Lactation Study. Breastfeed Med. 2022 Jun;17(6):493-500. doi: 10.1089/bfm.2021.0281. Epub 2022 Mar 10.
PubMed 35271380Pouch GG, Ebeling M, Shary JR, Hollis BW, Howard CR, Wagner CL. Evaluating Vitamin D Status in Infants Less than Seven Months; What Are the Preferred Biochemical Measurements? Breastfeed Med. 2022 May;17(5):422-428. doi: 10.1089/bfm.2021.0237. Epub 2022 Feb 23.
PubMed 35196139Wagner CL, Hulsey TC, Ebeling M, Shary JR, Asghari G, Howard CR, Baatz JE, Newton DA, Wahlquist AE, Reed SG, Taylor SN, Lawrence RA, Hollis BW. Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum. Breastfeed Med. 2020 Dec;15(12):765-775. doi: 10.1089/bfm.2020.0056. Epub 2020 Sep 11.
PubMed 32915638Bell KA, Wagner CL, Perng W, Feldman HA, Shypailo RJ, Belfort MB. Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr. 2018 May;196:168-174.e1. doi: 10.1016/j.jpeds.2018.01.028. Epub 2018 Mar 15.
PubMed 29551311Sen S, Penfield-Cyr A, Hollis BW, Wagner CL. Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr. 2017 Aug;187:147-152.e1. doi: 10.1016/j.jpeds.2017.04.024. Epub 2017 May 23.
PubMed 28549637Hollis BW, Wagner CL, Howard CR, Ebeling M, Shary JR, Smith PG, Taylor SN, Morella K, Lawrence RA, Hulsey TC. Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):625-34. doi: 10.1542/peds.2015-1669.
PubMed 26416936
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishing the Vitamin D Requirements During Lactation
- ClinicalTrials.gov ID
- NCT00412074
- Acronym / sponsor ID
- HD047511
- Conditions
- Vitamin D Deficiency
- Keywords
- Breastfeeding, Vitamin D, Vitamin D deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 460 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Aug 2006
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 15 Dec 2006 (estimated)
- Results
- Posted 3 Jun 2016
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 the effectiveness and safety of maternal and infant vitamin D supplementation as a function of ethnicity and latitude in the prevention of vitamin D deficiency in the breastfeeding mother-infant pair. The findings of this study will generate important new information for health care professionals and policy makers with regard to vitamin D requirements and the potential benefit to both mother and infant
Detailed description
Mothers from two study sites at different latitudes will be randomized to receive 1 of 3 treatment regimes of vitD3. Mothers, lactating or nonlactating controls will be randomized to either Group A: standard treatment(400 IU D3/d), Group B: (2,400 IU D3/d), or Group C: (6,400 IU D3/d. Infants of mothers randomized to Group A will receive 400 IU D3/d (recommended practice) and infants of mothers assigned to Groups B or C will receive placebo. On 2/5/2009, the protocol was amended and the Group B arm was dropped; infants of active subjects randomized to Group B as of 2/5/2009 were put on open label treatment (400 IU D3/d) through study completion. Newly enrolled subjects after this date were randomized to Group A or Group C only.
By measuring an array of indicators,calcium homeostasis and skeletal remodeling in the postpartum mother and the breastfeeding infant will be monitored. Through this study, the prevalence of vitD deficiency in the breastfeeding dyad and the utility of maternal therapeutic intervention with VitD3 will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control 400 IU vitamin D3 | Active comparator | Drug: 400 IU Vitamin D3 (cholecalciferol)400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad |
| 2400 IU vitamin D3 (cholecalciferol) | Experimental | Drug: 2400 IU Vitamin D3 (cholecalciferol)2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant |
| 6400 IU vitamin D3 (cholecalciferol) | Experimental | Drug: 6400 IU Vitamin D3 (cholecalciferol)6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Mother plans to breastfeed exclusively for at least six months
- Mother is in good health
- Infant is 35 weeks' gestation or greater
- Breastfeeding infant is in good health ( Level I nursery; or Level II nursery but not requiring oxygen therapy or parenteral nutrition beyond first 72 hours).
Key exclusion criteria (6 listed)
- Mother does not plan to breastfeed exclusively for the first six months (plans to use formula for infant's feedings during the first six months
- Infant has been admitted to Neonatal Intensive Care unit requiring oxygen therapy or parental nutrition beyond the first 72 hours
- Infant is less than 35 weeks' gestation
- Infant has been diagnosed with a congenital anomaly or abnormal chromosomal pattern
- Mother has a history of endocrine dysfunction involving parathyroid gland, diabetes, or calcium abnormalities related to renal disease such that calcium parameters are abnormal
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 |
|---|---|---|
| 400 IU Vitamin D3 (cholecalciferol)400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant | Drug | Control 400 IU vitamin D3 |
| 2400 IU Vitamin D3 (cholecalciferol)2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant | Drug | 2400 IU vitamin D3 (cholecalciferol) |
| 6400 IU Vitamin D3 (cholecalciferol)6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant | Drug | 6400 IU vitamin D3 (cholecalciferol) |
Primary outcome
25-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery
Time frame: to 7 months postpartum
2 secondary outcomes
Maternal Health Status - Vitamin D Deficiency
Time frame: to 7 months postpartum
Infant Health Status - Vitamin D Deficiency
Time frame: to 7 months of age
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35909001Ramadurai S, Andrews C, Cheema S, Thomas R, Wagner CL, Sen S. Maternal Predictors of Breast Milk Plasmalogens and Associations with Infant Body Composition and Neurodevelopment. Clin Ther. 2022 Jul;44(7):998-1009. doi: 10.1016/j.clinthera.2022.06.003. Epub 2022 Jul 29.
- Derived from this study: PubMed 35271380Andrews L, Phlegar K, Baatz JE, Ebeling MD, Shary JR, Gregoski MJ, Howard CR, Hollis BW, Wagner CL. Comparison of Infant Bone Mineral Content and Density After Infant Daily Oral Vit D 400 IU Supplementation Versus Nursing Mother Oral 6,400 IU Supplementation: A Randomized Controlled Lactation Study. Breastfeed Med. 2022 Jun;17(6):493-500. doi: 10.1089/bfm.2021.0281. Epub 2022 Mar 10.
- Derived from this study: PubMed 35196139Pouch GG, Ebeling M, Shary JR, Hollis BW, Howard CR, Wagner CL. Evaluating Vitamin D Status in Infants Less than Seven Months; What Are the Preferred Biochemical Measurements? Breastfeed Med. 2022 May;17(5):422-428. doi: 10.1089/bfm.2021.0237. Epub 2022 Feb 23.
- Derived from this study: PubMed 32915638Wagner CL, Hulsey TC, Ebeling M, Shary JR, Asghari G, Howard CR, Baatz JE, Newton DA, Wahlquist AE, Reed SG, Taylor SN, Lawrence RA, Hollis BW. Safety Aspects of a Randomized Clinical Trial of Maternal and Infant Vitamin D Supplementation by Feeding Type Through 7 Months Postpartum. Breastfeed Med. 2020 Dec;15(12):765-775. doi: 10.1089/bfm.2020.0056. Epub 2020 Sep 11.
- Derived from this study: PubMed 29551311Bell KA, Wagner CL, Perng W, Feldman HA, Shypailo RJ, Belfort MB. Validity of Body Mass Index as a Measure of Adiposity in Infancy. J Pediatr. 2018 May;196:168-174.e1. doi: 10.1016/j.jpeds.2018.01.028. Epub 2018 Mar 15.
- Derived from this study: PubMed 28549637Sen S, Penfield-Cyr A, Hollis BW, Wagner CL. Maternal Obesity, 25-Hydroxy Vitamin D Concentration, and Bone Density in Breastfeeding Dyads. J Pediatr. 2017 Aug;187:147-152.e1. doi: 10.1016/j.jpeds.2017.04.024. Epub 2017 May 23.
- Derived from this study: PubMed 26416936Hollis BW, Wagner CL, Howard CR, Ebeling M, Shary JR, Smith PG, Taylor SN, Morella K, Lawrence RA, Hulsey TC. Maternal Versus Infant Vitamin D Supplementation During Lactation: A Randomized Controlled Trial. Pediatrics. 2015 Oct;136(4):625-34. doi: 10.1542/peds.2015-1669.
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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.
Bruce W. Hollis, Ph.D principal investigator
Medical University of South Carolina
Carol L. Wagner, MD principal investigator
Medical University of South Carolina
Thomas C. Hulsey, Ph.D study chair
Medical University of South Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 400 IU Vitamin D3 (cholecalciferol), 2400 IU Vitamin D3 (cholecalciferol) and 6400 IU Vitamin D3 (cholecalciferol) in people with Vitamin D Deficiency, run by Medical University of South Carolina at 2 sites in United States.
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 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: finished, as of the sponsor's last update on 4 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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-Hydroxyvitamin D Levels for Postpartum Mother 7 Months After Delivery (time frame: to 7 months postpartum). 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 NCT00412074, which also lists 7 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 4 Jun 2018.