An interventional study of Vitamin D3 and Multivitamin in Osteoporosis, sponsored by Leigh Eck, MD. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-18.
Sponsored by Leigh Eck, MD · Not applicable, Interventional, and Prevention
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.
1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.
This study's enrollment of 22 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →This is the only study on the registry with Leigh Eck, MD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
4000IU Vitamin D3 in tablet taken daily with multivitamin
Drug: Vitamin D3
Multivitamin with 400IU vitamin D tablet
Dietary Supplement: Multivitamin
4000IU vitamin D3 tablet taken daily
Multivitamin containing 400IU vitamin D in tablet taken daily
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Time frame: Change from Baseline to 6 months
Change in 25-hyroxyvitamin D Levels at 3 Months
Difference in means between visits
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
difference in mean
Time frame: Change from Baseline to 3 Months
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
difference in the mean
Time frame: Change from Baseline to 6 Months
| Milestone | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Started | 12 | 10 |
| 3 month visit | 10 | 10 |
| 6 month visit | 9 | 10 |
| Completed | 7 | 7 |
| Not completed | 5 | 3 |
| Withdrew: Pregnancy | 2 | 3 |
| Withdrew: Lost to follow-up | 3 | 0 |
| grams/cm^2 | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in Bone Mineral Density (BMD) in HIP at 6 Months | -0.041 ± 0.014 | 0.011 ± 0.122 |
Difference in means between visits
| ng/ml | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in 25-hyroxyvitamin D Levels at 3 Months | 2.600 ± 7.230 | -5.850 ± 7.713 |
| ng/ml | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in 25-hyroxyvitamin D Levels at 6 Months | 1.889 ± 7.865 | -3.200 ± 13.774 |
| grams/cm^2 | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in Bone Mineral Density (BMD) at HIP at 3 Months | -0.017 ± 0.009 | -0.016 ± 0.022 |
difference in mean
| grams/cm^2 | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months | -0.025 ± 0.071 | -0.025 ± 0.030 |
difference in the mean
| grams/cm^2 | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | -0.060 ± 0.036 | -0.109 ± 0.115 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vitamin D - Experimental | — | 0/12 (0%) | 1/12 (8.3%) |
| Multivitamin - Active Comparator | — | 0/10 (0%) | 0/10 (0%) |
| Event | Vitamin D - Experimental | Multivitamin - Active Comparator |
|---|---|---|
| ConstipationGastrointestinal disorders | 1/12 | 0/10 |
| Age, Continuous(years) | Vitamin D - Experimental | Multivitamin - Active Comparator | Total |
|---|---|---|---|
| Mean | 29 ± 6 | 32 ± 3 | 30 ± 4.64 |
| Sex: Female, Male(Participants) | Vitamin D - Experimental | Multivitamin - Active Comparator | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Vitamin D - Experimental | Multivitamin - Active Comparator | Total |
|---|---|---|---|
| United States | 12 | 10 | 22 |
This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.
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