Osteoporosis
Conditions
Brief 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. 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.
Interventions
DRUGVitamin D3
4000IU vitamin D3 tablet taken daily
DIETARY_SUPPLEMENTMultivitamin
Multivitamin containing 400IU vitamin D in tablet taken daily
Sponsors
Bio-Tech Pharmacal, Inc.
Leigh Eck, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Fully lactating mothers age 18 and up * Within 1 month after delivery * Plan to breast feed for at least 6 months
Exclusion criteria
* Known metabolic bone disease * Chronic renal insufficiency * Chronic corticosteroid use * Eating disorder * Estrogen containing hormonal contraception use * Daily use of \>400IU Vitamin D supplementation * Delivery of Multiples * Delivery of a singleton with a birth weight of \<2500 grams * Preterm delivery of baby * History of kidney stones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Bone Mineral Density (BMD) in HIP at 6 Months | Change from Baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 25-hyroxyvitamin D Levels at 3 Months | Change from Baseline to 3 Months | Difference in means between visits |
| Change in 25-hyroxyvitamin D Levels at 6 Months | Change from Baseline to 6 Months | — |
| 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 | Change from Baseline to 3 Months | difference in mean |
| Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | Change from Baseline to 6 Months | difference in the mean |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Vitamin D - Experimental 4000IU Vitamin D3 in tablet taken daily with multivitamin
Vitamin D3: 4000IU vitamin D3 tablet taken daily | 12 |
| Multivitamin - Active Comparator Multivitamin with 400IU vitamin D tablet
Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily | 10 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Pregnancy | 2 | 3 |
Baseline characteristics
| Characteristic | Vitamin D - Experimental | Multivitamin - Active Comparator | Total |
|---|---|---|---|
| Age, Continuous | 29 years STANDARD_DEVIATION 6 | 32 years STANDARD_DEVIATION 3 | 30 years STANDARD_DEVIATION 4.64 |
| Region of Enrollment United States | 12 participants | 10 participants | 22 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 12 | 0 / 10 |
| serious Total, serious adverse events | 0 / 12 | 0 / 10 |
Outcome results
Primary
Change in Bone Mineral Density (BMD) in HIP at 6 Months
Time frame: Change from Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in Bone Mineral Density (BMD) in HIP at 6 Months | -0.041 grams/cm^2 | Standard Deviation 0.014 |
| Multivitamin - Active Comparator | Change in Bone Mineral Density (BMD) in HIP at 6 Months | 0.011 grams/cm^2 | Standard Deviation 0.122 |
Secondary
Change in 25-hyroxyvitamin D Levels at 3 Months
Difference in means between visits
Time frame: Change from Baseline to 3 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in 25-hyroxyvitamin D Levels at 3 Months | 2.600 ng/ml | Standard Deviation 7.23 |
| Multivitamin - Active Comparator | Change in 25-hyroxyvitamin D Levels at 3 Months | -5.850 ng/ml | Standard Deviation 7.713 |
Secondary
Change in 25-hyroxyvitamin D Levels at 6 Months
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in 25-hyroxyvitamin D Levels at 6 Months | 1.889 ng/ml | Standard Deviation 7.865 |
| Multivitamin - Active Comparator | Change in 25-hyroxyvitamin D Levels at 6 Months | -3.200 ng/ml | Standard Deviation 13.774 |
Secondary
Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months
difference in mean
Time frame: Change from Baseline to 3 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months | -0.025 grams/cm^2 | Standard Deviation 0.071 |
| Multivitamin - Active Comparator | Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months | -0.025 grams/cm^2 | Standard Deviation 0.03 |
Secondary
Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months
difference in the mean
Time frame: Change from Baseline to 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | -0.060 grams/cm^2 | Standard Deviation 0.036 |
| Multivitamin - Active Comparator | Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months | -0.109 grams/cm^2 | Standard Deviation 0.115 |
Secondary
Change in Bone Mineral Density (BMD) at HIP at 3 Months
Time frame: Change from Baseline to 3 months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vitamin D - Experimental | Change in Bone Mineral Density (BMD) at HIP at 3 Months | -0.017 grams/cm^2 | Standard Deviation 0.009 |
| Multivitamin - Active Comparator | Change in Bone Mineral Density (BMD) at HIP at 3 Months | -0.016 grams/cm^2 | Standard Deviation 0.022 |