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Completed

NCT Number: NCT00903344

Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

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.

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Key information

Conditions

Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Missouri, 66160, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin D3

Drug

4000IU vitamin D3 tablet taken daily

Multivitamin

Dietary Supplement

Multivitamin containing 400IU vitamin D in tablet taken daily

Primary outcomes

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

    Time frame: Change from Baseline to 6 months

Secondary outcomes

  1. Change in 25-hyroxyvitamin D Levels at 3 Months

    Time frame: Change from Baseline to 3 Months

    Difference in means between visits

  2. Change in 25-hyroxyvitamin D Levels at 6 Months

    Time frame: Change from Baseline to 6 Months

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

    Time frame: Change from Baseline to 3 months

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

    Time frame: Change from Baseline to 3 Months

    difference in mean

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

    Time frame: Change from Baseline to 6 Months

    difference in the mean

Sponsors and collaborators

Lead sponsor

Leigh Eck, MD

Other

Collaborators

  • Bio-Tech Pharmacal, Inc.

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
May 18, 2009
Registry last updated
Aug 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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