OsteoporosisNCT00903344
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
A study testing Vitamin D3 and Multivitamin in people with Osteoporosis, run by Leigh Eck, MD at 1 site in United States.
Trial summary
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Vitamin D3 and Multivitamin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2012
- Phase
- Interventional
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fully lactating mothers age 18 and up
- Within 1 month after delivery
- Plan to breast feed for at least 6 months
Who cannot join
- Known metabolic bone disease
- Chronic renal insufficiency
- Chronic corticosteroid use
- Eating disorder
- Estrogen containing hormonal contraception use
- Daily use of >400IU Vitamin D supplementation
Show all 10Show fewer
- Delivery of Multiples
- Delivery of a singleton with a birth weight of <2500 grams
- Preterm delivery of baby
- History of kidney stones
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Missouri, 66160
About this study
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.
Read the detailed description
Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.
Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.
- Conditions
- Osteoporosis
- Being tested
- Vitamin D3, Multivitamin
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
4000IU vitamin D3 tablet taken daily
MultivitaminDietary supplement
Multivitamin containing 400IU vitamin D in tablet taken daily
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Experimental | 4000IU Vitamin D3 in tablet taken daily with multivitamin Receives: Drug: Vitamin D3 |
| Multivitamin | Active comparator | Multivitamin with 400IU vitamin D tablet Receives: Dietary Supplement: Multivitamin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Measured: Change from Baseline to 6 months
Secondary outcomes (5)
Change in 25-hyroxyvitamin D Levels at 3 Months
Difference in means between visits
Measured: Change from Baseline to 3 Months
Change in 25-hyroxyvitamin D Levels at 6 Months
Measured: Change from Baseline to 6 Months
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Measured: Change from Baseline to 3 months
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
difference in mean
Measured: Change from Baseline to 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
difference in the mean
Measured: Change from Baseline to 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 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.
- Other trials for OsteoporosisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leigh Eck, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Bio-Tech Pharmacal, Inc.
- Responsible party
- Sponsor-investigator, Leigh Eck, MD, University of Kansas Medical Center
- Investigators
- Leigh Eck, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903344
- Sponsor's protocol ID
- 11711
- Status last verified
- Aug 2014
- First submitted
- 14 May 2009
- Last updated
- 18 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
- ClinicalTrials.gov ID
- NCT00903344
- Acronym / sponsor ID
- 11711
- Conditions
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Leigh Eck, MDUniversity, hospital or other
- Collaborators
- Bio-Tech Pharmacal, Inc.
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Posted 18 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Studies have shown that lactation is associated with a loss of bone density from four to seven percent at the spine and hip among women who lactate for six months. Decline in bone density with lactation occurs rapidly. Although bone density increases after weaning, there is controversy on whether or not it is completely restored. Epidemiological studies find no significant negative impact of lactation on bone mass or fractures, and in fact there is evidence that lactation has a positive effect on bone mass. We think that interventions that attenuate this physiologic loss of bone that is associated with lactation and accelerate restoration of bone mass after weaning may result in improved long term bone mass and diminished fracture risk.
Detailed description
Adequate vitamin D stores are necessary for skeletal health. Vitamin D deficiency is pronounced in women of child bearing age as well as pregnant women in the United States. This study will provide important information about whether vitamin D supplementation may positively impact the normal physiologic loss of bone mass that is observed during lactation.
Recruitment will begin while subjects are pregnant in order to expedite entry into the study in the immediate post-partum period. If subjects are deemed eligible during pregnancy, contact information to include name, address, expected delivery date and two contact phone numbers will be obtained. Subjects will be contacted two weeks prior to expected delivery date and then again at expected delivery date. Subjects will be followed for a total of 18 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Experimental | Drug: Vitamin D34000IU Vitamin D3 in tablet taken daily with multivitamin |
| Multivitamin | Active comparator | Dietary Supplement: MultivitaminMultivitamin with 400IU vitamin D tablet |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Fully lactating mothers age 18 and up
- Within 1 month after delivery
- Plan to breast feed for at least 6 months
Key exclusion criteria (10 listed)
- Known metabolic bone disease
- Chronic renal insufficiency
- Chronic corticosteroid use
- Eating disorder
- Estrogen containing hormonal contraception use
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 D34000IU vitamin D3 tablet taken daily | Drug | Vitamin D |
| MultivitaminMultivitamin containing 400IU vitamin D in tablet taken daily | Dietary supplement | Multivitamin |
Primary outcome
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Time frame: Change from Baseline to 6 months
5 secondary outcomes
Change in 25-hyroxyvitamin D Levels at 3 Months
Time frame: Change from Baseline to 3 Months
Change in 25-hyroxyvitamin D Levels at 6 Months
Time frame: Change from Baseline to 6 Months
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Time frame: Change from Baseline to 3 months
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
Time frame: Change from Baseline to 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
Time frame: Change from Baseline to 6 Months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Leigh Eck, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 and Multivitamin in people with Osteoporosis, run by Leigh Eck, MD 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 3 inclusion and 10 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 18 Aug 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 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Aug 2014). 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?
Change in Bone Mineral Density (BMD) in HIP at 6 Months (time frame: Change from Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2014.