Official Title

Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
  • Phase

    N/A
  • Study Type

    Interventional
  • Study Participants

    22
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.
Study Started
Dec 31
2009
Primary Completion
Jun 30
2012
Study Completion
Jun 30
2012
Results Posted
Aug 18
2014
Estimate
Last Update
Aug 18
2014
Estimate

Drug Vitamin D3

4000IU vitamin D3 tablet taken daily

Dietary Supplement Multivitamin

Multivitamin containing 400IU vitamin D in tablet taken daily

Vitamin D Experimental

4000IU Vitamin D3 in tablet taken daily with multivitamin

Multivitamin Active Comparator

Multivitamin with 400IU vitamin D tablet

Criteria

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

Summary

Vitamin D - Experimental

Multivitamin - Active Comparator

All Events

Event Type Organ System Event Term Vitamin D - Experimental Multivitamin - Active Comparator

Change in Bone Mineral Density (BMD) in HIP at 6 Months

Vitamin D - Experimental

-0.041
grams/cm^2 (Mean)
Standard Deviation: 0.014

Multivitamin - Active Comparator

0.011
grams/cm^2 (Mean)
Standard Deviation: 0.122

Change in 25-hyroxyvitamin D Levels at 3 Months

Difference in means between visits

Vitamin D - Experimental

2.6
ng/ml (Mean)
Standard Deviation: 7.230

Multivitamin - Active Comparator

-5.85
ng/ml (Mean)
Standard Deviation: 7.713

Change in 25-hyroxyvitamin D Levels at 6 Months

Vitamin D - Experimental

1.889
ng/ml (Mean)
Standard Deviation: 7.865

Multivitamin - Active Comparator

-3.2
ng/ml (Mean)
Standard Deviation: 13.774

Change in Bone Mineral Density (BMD) at HIP at 3 Months

Vitamin D - Experimental

-0.017
grams/cm^2 (Mean)
Standard Deviation: 0.009

Multivitamin - Active Comparator

-0.016
grams/cm^2 (Mean)
Standard Deviation: 0.022

Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months

difference in mean

Vitamin D - Experimental

-0.025
grams/cm^2 (Mean)
Standard Deviation: 0.071

Multivitamin - Active Comparator

-0.025
grams/cm^2 (Mean)
Standard Deviation: 0.030

Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months

difference in the mean

Vitamin D - Experimental

-0.06
grams/cm^2 (Mean)
Standard Deviation: 0.036

Multivitamin - Active Comparator

-0.109
grams/cm^2 (Mean)
Standard Deviation: 0.115

Total

22
Participants

Age, Continuous

30
years (Mean)
Standard Deviation: 4.64

Region of Enrollment

Sex: Female, Male

Overall Study

Vitamin D - Experimental

Multivitamin - Active Comparator

Drop/Withdrawal Reasons

Vitamin D - Experimental

Multivitamin - Active Comparator