Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Vitamin D3
* Dietary Supplement: Multivitamin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin D<br>4000IU Vitamin D3 in tablet taken daily with multivitamin | Drug: Vitamin D3<br>* 4000IU vitamin D3 tablet taken daily<br>|
| Active Comparator: Multivitamin<br>Multivitamin with 400IU vitamin D tablet | Dietary Supplement: Multivitamin<br>* Multivitamin containing 400IU vitamin D in tablet taken daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Bone Mineral Density (BMD) in HIP at 6 Months |  | Change from Baseline to 6 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 |