N/A
N=22
Impact of Vitamin D Supplementation on Lactation Associated Bone Loss
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00903344 ↗Enrolled (actual)
22
Serious AEs
0.0%
Results posted
Aug 2014
Primary outcome: Primary: Change in Bone Mineral Density (BMD) in HIP at 6 Months — -0.041; 0.011 grams/cm^2
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vitamin D3 (Drug); Multivitamin (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Leigh Eck, MD
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Bone Mineral Density (BMD) in HIP at 6 Months |
-0.041; 0.011 | — |
| SECONDARY Change in 25-hyroxyvitamin D Levels at 3 Months |
2.600; -5.850 | — |
| SECONDARY Change in 25-hyroxyvitamin D Levels at 6 Months |
1.889; -3.200 | — |
| SECONDARY Change in Bone Mineral Density (BMD) at HIP at 3 Months |
-0.017; -0.016 | — |
| SECONDARY Change in Bone Mineral Denisty (BMD) in SPINE at 3 Months |
-0.025; -0.025 | — |
| SECONDARY Change in Bone Mineral Denisty (BMD) in SPINE at 6 Months |
-0.060; -0.109 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00903344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.