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| Name | Class |
|---|---|
| Bio-Tech Pharmacal, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin D | Experimental | 4000IU Vitamin D3 in tablet taken daily with multivitamin |
|
| Multivitamin | Active Comparator | Multivitamin with 400IU vitamin D tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D3 | Drug | 4000IU vitamin D3 tablet taken daily |
| |
| Multivitamin |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bone Mineral Density (BMD) in HIP at 6 Months | Change from Baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in 25-hyroxyvitamin D Levels at 3 Months | Difference in means between visits | Change from Baseline to 3 Months |
| Change in 25-hyroxyvitamin D Levels at 6 Months | Change from Baseline to 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leigh Eck, MD | University of Kansas Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Kansas Medical Center | Kansas City | Missouri | 66160 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Vitamin D - Experimental | 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily |
| FG001 | Multivitamin - Active Comparator | Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Vitamin D - Experimental | 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily |
| BG001 | Multivitamin - Active Comparator |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Bone Mineral Density (BMD) in HIP at 6 Months | Posted | Mean | Standard Deviation | grams/cm^2 | Change from Baseline to 6 months |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vitamin D - Experimental | 4000IU Vitamin D3 in tablet taken daily with multivitamin Vitamin D3: 4000IU vitamin D3 tablet taken daily |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Leigh Eck | University of Kansas Medical Center | 913-588-6022 | leck2@kumc.edu |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| C067316 | Geritol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| Dietary Supplement |
Multivitamin containing 400IU vitamin D in tablet taken daily |
|
| Change in Bone Mineral Density (BMD) at HIP at 3 Months | Change from Baseline to 3 months |
| Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months | difference in mean | Change from Baseline to 3 Months |
| Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | difference in the mean | Change from Baseline to 6 Months |
Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Change in 25-hyroxyvitamin D Levels at 3 Months | Difference in means between visits | At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for two of the groups' participants was not included in the results. | Posted | Mean | Standard Deviation | ng/ml | Change from Baseline to 3 Months |
|
|
|
| Secondary | Change in 25-hyroxyvitamin D Levels at 6 Months | Posted | Mean | Standard Deviation | ng/ml | Change from Baseline to 6 Months |
|
|
|
| Secondary | Change in Bone Mineral Density (BMD) at HIP at 3 Months | At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results. | Posted | Mean | Standard Deviation | grams/cm^2 | Change from Baseline to 3 months |
|
|
|
| Secondary | Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months | difference in mean | At 3 month visit there had been two participants that dropped out in the Vitamin D - Experimental group. No participants had dropped out in the Multivitamin - Active Comparator group but the test for this specific outcome measure for one of the group's participants was not included in the results. | Posted | Mean | Standard Deviation | grams/cm^2 | Change from Baseline to 3 Months |
|
|
|
| Secondary | Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | difference in the mean | Posted | Mean | Standard Deviation | grams/cm^2 | Change from Baseline to 6 Months |
|
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| EG001 | Multivitamin - Active Comparator | Multivitamin with 400IU vitamin D tablet Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily | 0 | 10 | 0 | 10 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |