Impact of Vitamin D Supplementation on Lactation Associated Bone Loss - Full Text View

Sponsor:	University of Kansas
Collaborator:	Bio-Tech Pharmacal, Inc.
Information provided by:	University of Kansas
ClinicalTrials.gov Identifier:	NCT00903344

Purpose

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.

Condition	Intervention
Osteoporosis	Dietary Supplement: Vitamin D3 Dietary Supplement: Multivitamin

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention
Official Title:	Impact of Vitamin D Supplementation on Lactation Associated Bone Loss

Resource links provided by NLM:

MedlinePlus related topics: Bone Density Breast Feeding Osteoporosis Vitamin D

Drug Information available for: Cholecalciferol Vitamin D

U.S. FDA Resources

Further study details as provided by University of Kansas:

Primary Outcome Measures:

Change in absolute bone mineral density (BMD) [ Time Frame: Baseline, 3 months, 6 months, 1 year, 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in lab values for vitamin D, calcium, parathyroid hormone, bone turnover markers, calcium-to-creatinine ratio [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	25
Study Start Date:	December 2009
Estimated Study Completion Date:	June 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 4000IU Vitamin D3 in tablet taken daily with multivitamin	Dietary Supplement: Vitamin D3 4000IU vitamin D3 tablet taken daily
Active Comparator: 2 Multivitamin with 400IU vitamin D tablet	Dietary Supplement: Multivitamin Multivitamin containing 400IU vitamin D in tablet taken daily

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00903344

Locations

United States, Missouri
University of Kansas Medical Center
Kansas City, Missouri, United States, 66160

Sponsors and Collaborators

University of Kansas

Bio-Tech Pharmacal, Inc.

Investigators

Principal Investigator:

Leigh Eck, MD

University of Kansas

More Information

No publications provided

Responsible Party:	Leigh Eck, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:	NCT00903344 History of Changes
Other Study ID Numbers:	11711
Study First Received:	May 14, 2009
Last Updated:	July 14, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Cholecalciferol
Vitamin D
Ergocalciferols

Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on February 09, 2012