Vitamin D DeficiencyPhase 2/3NCT01240265
Vitamin D Supplementation in Breastfeeding Women
A Phase 2/3 study testing Vitamin D3 in people with Vitamin D Deficiency and Rickets, run by Mayo Clinic at 1 site in United States.
Trial summary
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Read more about this study
- Who is it for?
- Ages 1 month to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Vitamin D Deficiency, Rickets, Infant Nutrition Disorders
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Aug 2011
- Phase
- Phase 2/3
- 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 1 month to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Currently lactating mothers at least 18 years of age
- Willing to continue exclusively breastfeeding their infant throughout the study interval
- The infant is 1-6 months of age at the beginning of the study
- Willing and able to participate in all aspects of the study
- Mother and infant are in good health, as determined by the study investigator
- Have been provided with, understand, and have signed the informed consent for themselves and their child.
Who cannot join
- Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
- Have recently or plan to engage in indoor tanning
- Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
- Are nursing multiple infants (e.g. twins)
- Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
- Are taking greater than the standard daily dose of 400 IU of vitamin D found in prenatal vitamins
Show all 9Show fewer
- Infant weight below 1.67 kg
- Mothers with baseline 25(OH)D levels >70 ng/ml, and/or infants with baseline 25(OH)D levels >70 ng/ml
- History of kidney stones
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
- Conditions
- Vitamin D Deficiency, Rickets, Infant Nutrition Disorders
- Being tested
- Vitamin D3
- Keywords
- Vitamin D deficiency, Rickets, Infant, Nutrition
- Medical subject headings
- Vitamin D Deficiency, Rickets, Infant Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Dietary supplement
Also called Cholecalciferol
150,000 IU orally given once
Vitamin D3Dietary supplement
Also called Cholecalciferol
5000 IU given orally daily for 28 days
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D 150,000 units once | Experimental | Single dose of vitamin D3 150,000 IU given orally once Receives: Dietary Supplement: Vitamin D3 |
| Vitamin D 5000 units daily | Experimental | Vitamin D3 5000 IU daily given orally for 28 days Receives: Dietary Supplement: Vitamin D3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of days of detectable milk vitamin D concentrations
To compare the number of days of detectable milk vitamin D concentrations and incremental area under the curve between two dosing regimens of oral cholecalciferol in lactating mothers.
Measured: 28 days
Secondary outcomes (1)
Infant serum 25(OH)D concentration
To compare the change in serum 25(OH)D concentrations in infants receiving milk from mothers supplemented with either 5,000 IU daily or 150,000 IU monthly cholecalciferol
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Mayo ClinicThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Thacher, Mayo Clinic
- Investigators
- Thomas Thacher, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240265
- Sponsor's protocol ID
- 10-004130
- Status last verified
- Apr 2013
- First submitted
- 10 Nov 2010
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Ketha H, Thacher TD, Oberhelman SS, Fischer PR, Singh RJ, Kumar R. Comparison of the effect of daily versus bolus dose maternal vitamin D3 supplementation on the 24,25-dihydroxyvitamin D3 to 25-hydroxyvitamin D3 ratio. Bone. 2018 May;110:321-325. doi: 10.1016/j.bone.2018.02.024. Epub 2018 Feb 24.
PubMed 29486367Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, Gardner BM, Pettifor JM, Croghan IT, Thacher TD. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1378-87. doi: 10.1016/j.mayocp.2013.09.012.
PubMed 24290111
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Oral Vitamin D Supplementation Via Daily or Monthly Regimens and the Effect on Levels of Vitamin D in Human Milk and Infant Serum
- ClinicalTrials.gov ID
- NCT01240265
- Acronym / sponsor ID
- 10-004130
- Conditions
- Vitamin D Deficiency, Rickets, Infant Nutrition Disorders
- Keywords
- Vitamin D deficiency, Rickets, Infant, Nutrition
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 15 Nov 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.
Adequate vitamin D is essential for proper infant growth and development. However, human milk is low in vitamin D, and most infants do not receive recommended supplementation. Our aim is to assess the feasibility of providing adequate vitamin D to breastfed infants through maternal vitamin D supplementation. Forty non-pregnant, lactating women at least 18 years of age with exclusively breastfed infants between the ages of 1 and 6 months will be randomized to receive oral vitamin D as either 5,000 IU daily for 28 days or 150,000 IU as a single dose. Maternal serum calcium, phosphorus, vitamin D and 25(OH)D; maternal urinary calcium; maternal milk vitamin D and 25(OH)D will be measured on days 0, 1, 3, 7, 14, and 28 of the study; and infant serum vitamin D and 25(OH)D will be measured on days 0 and 28.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D 150,000 units once | Experimental | Dietary Supplement: Vitamin D3Single dose of vitamin D3 150,000 IU given orally once |
| Vitamin D 5000 units daily | Experimental | Dietary Supplement: Vitamin D3Vitamin D3 5000 IU daily given orally for 28 days |
Who may qualify
- Ages
- 1 month to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Currently lactating mothers at least 18 years of age
- Willing to continue exclusively breastfeeding their infant throughout the study interval
- The infant is 1-6 months of age at the beginning of the study
- Willing and able to participate in all aspects of the study
- Mother and infant are in good health, as determined by the study investigator
Key exclusion criteria (9 listed)
- Have recently travelled (within the preceding 30 days) or plan to travel south of 35 degrees north latitude during the study interval
- Have recently or plan to engage in indoor tanning
- Are currently taking medications that affect vitamin D metabolism, like steroids, anticonvulsants, or barbiturates
- Are nursing multiple infants (e.g. twins)
- Are taking greater than the daily recommended intake of 1000 mg elemental calcium as calcium supplements
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 D3Also: Cholecalciferol150,000 IU orally given once | Dietary supplement | Vitamin D 150,000 units once |
| Vitamin D3Also: Cholecalciferol5000 IU given orally daily for 28 days | Dietary supplement | Vitamin D 5000 units daily |
Primary outcome
The number of days of detectable milk vitamin D concentrations
Time frame: 28 days
To compare the number of days of detectable milk vitamin D concentrations and incremental area under the curve between two dosing regimens of oral cholecalciferol in lactating mothers.
1 secondary outcome
Infant serum 25(OH)D concentration
Time frame: 28 days
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 30 Apr 2013.
- Derived from this study: PubMed 29486367Ketha H, Thacher TD, Oberhelman SS, Fischer PR, Singh RJ, Kumar R. Comparison of the effect of daily versus bolus dose maternal vitamin D3 supplementation on the 24,25-dihydroxyvitamin D3 to 25-hydroxyvitamin D3 ratio. Bone. 2018 May;110:321-325. doi: 10.1016/j.bone.2018.02.024. Epub 2018 Feb 24.
- Derived from this study: PubMed 24290111Oberhelman SS, Meekins ME, Fischer PR, Lee BR, Singh RJ, Cha SS, Gardner BM, Pettifor JM, Croghan IT, Thacher TD. Maternal vitamin D supplementation to improve the vitamin D status of breast-fed infants: a randomized controlled trial. Mayo Clin Proc. 2013 Dec;88(12):1378-87. doi: 10.1016/j.mayocp.2013.09.012.
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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.
Thomas Thacher, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin D3 in people with Vitamin D Deficiency and Rickets, run by Mayo Clinic at 1 site 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 6 inclusion and 9 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 30 Apr 2013. 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 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
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?
The number of days of detectable milk vitamin D concentrations (time frame: 28 days). 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 NCT01240265, which also lists 2 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 30 Apr 2013.