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The Effect of Vitamin D Supplementation During Caloric Restriction on Intestinal Calcium Absorption

This study is currently recruiting participants.
Verified by National Institute on Aging (NIA), September 2008

Sponsors and Collaborators: National Institute on Aging (NIA)
Rutgers University
Information provided by: National Institute on Aging (NIA)
ClinicalTrials.gov Identifier: NCT00472654
  Purpose

The purpose of this study is to learn how the amount of vitamin D supplementation influences intestinal fractional calcium absorption (a measure of the amount of calcium absorbed).


Condition Intervention
Weight Loss
Bone Density
Behavioral: Weight Loss
Dietary Supplement: Vitamin D 1200 IU
Behavioral: Weight Maintenance

MedlinePlus related topics:   Dietary Supplements    Weight Control   

Drug Information available for:   Calcium gluconate    Vitamin D    Ergocalciferol   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:   Nutritional Regulation of Bone - Aim 3

Further study details as provided by National Institute on Aging (NIA):

Primary Outcome Measures:
  • Changes in Calcium absorption [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in serum and urine bone markers, hormones, proteins and genes [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:   84
Study Start Date:   March 2007
Estimated Study Completion Date:   May 2011
Estimated Primary Completion Date:   May 2011 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
WL: Placebo Comparator Behavioral: Weight Loss
Diet for weight loss for 5 weeks; all weight loss participants will attend 5-6 weekly counseling sessions (about 50 minutes per session)
WL + D: Experimental Behavioral: Weight Loss
Diet for weight loss for 5 weeks; all weight loss participants will attend 5-6 weekly counseling sessions (about 50 minutes per session)
Dietary Supplement: Vitamin D 1200 IU
Daily Vitamin D 1200 IU supplement for 5 weeks
WM: Placebo Comparator Behavioral: Weight Maintenance
Diet for weight maintenance for 5 weeks
WM + D: Active Comparator Dietary Supplement: Vitamin D 1200 IU
Daily Vitamin D 1200 IU supplement for 5 weeks
Behavioral: Weight Maintenance
Diet for weight maintenance for 5 weeks

Detailed Description:

The extent of change in the amount of calcium that is absorbed with an increase in vitamin D supplementation is not known. This information is important for determining appropriate vitamin D requirements for optimal calcium absorption. During caloric restriction in postmenopausal women, we found that serum parathyroid hormone (PTH) explains 22% of the variance for the reduced calcium absorption (equivalent to 400 IU of Vitamin D per day). It is possible that higher dietary Vitamin D will increase serum 25-hydroxy-Vitamin D (25(OH)D) levels, offset serum PTH and thereby prevent a reduction in calcium absorption. This study seeks to determine if a high Vitamin D intake (a supplement of 1200 IU per day) can increase true fractional calcium absorption (TFCA) in postmenopausal women on a standard high-carbohydrate weight loss diet compared to weight maintenance, with the hypothesis that a high Vitamin D intake will raise serum 25(OH)D and offset the decline in TFCA during caloric restriction (vs. an increase in weight-stable women), and serum PTH will no longer be a major factor explaining changes in TFCA.

Participants will be recruited for both weight loss and weight maintenance, and all will be randomly assigned to take either 1200 IU per day vitamin D supplement or matching placebo. All weight loss participants will attend 5-6 weekly counseling sessions (about 50 minutes per session). All participants will be asked to take a daily vitamin/mineral supplement and, depending on their usual food intake, they may be asked to take a calcium tablet to meet the recommended intake throughout the study period. To measure calcium absorption before and after the 6 weeks of weight loss, participants will go to the study site after an overnight fast where an IV will be placed and the participant will receive an infusion of a stable calcium isotope and consume a 4 oz beverage that also contains a stable isotope of calcium. Blood will be drawn, and then the participant will be asked to collect all urine for the next 24 hours. Body composition (fat, muscle mass, and bone mineral density) will be measured by a dual-energy x-ray absorptiometry (DXA) machine and peripheral quantitative computer tomography (pQCT).

Participants will only be recruited in the winter and spring of each year.

  Eligibility
Ages Eligible for Study:   50 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Postmenopausal women who are more than 2 years since last menses
  • Obese or overweight
  • Must live in the geographic vicinity of Rutgers University

Exclusion Criteria:

  • Currently on any medication known to influence calcium or bone metabolism, including HRT, or with evidence of diseases known to influence calcium metabolism (i.e. metabolic bone disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, or renal disease, significant cardiac disease [i.e., heart attack or stroke in the past 6 months., abnormal EKG], active malignancy or cancer therapy within the past year)
  • History of kidney stones
  • Weight gain or weight loss (5% of body wt) within 3 months prior to recruitment
  • Participation in other investigational studies during the 12-month study period
  • Travel for longer than 2 consecutive weeks during the study period
  • Usually have a very high or low intake of calcium (more than 1500 or less than 500 mg per day)
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472654

Locations
United States, New Jersey
Rutgers University     Recruiting
      New Brunswick, New Jersey, United States, 08901
      Contact: Sue Shapses, PhD, RD     732-932-9403     shapses@aesop.rutgers.edu    
      Contact: Hasina Ambia-Sobhan     732-932-6656     togore@rci.rutgers.edu    
      Principal Investigator: Sue Shapses, PhD, RD            
      Sub-Investigator: Stephen Schneider, MD            
      Sub-Investigator: Robert Brolin, MD            

Sponsors and Collaborators

Investigators
Principal Investigator:     Sue Shapses, PhD, RD     Rutgers University, Nutritional Sciences    
  More Information


Publications:

Responsible Party:   Rutgers University ( Sue Shapses, PhD, RD )
Study ID Numbers:   AG0083, RO1-AG12161
First Received:   May 10, 2007
Last Updated:   September 11, 2008
ClinicalTrials.gov Identifier:   NCT00472654
Health Authority:   United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
bone mass  
calcium absorption  
bone quality  
fracture risk  

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Vitamin D
Weight Loss
Fractures, Bone
Ergocalciferols
Body Weight Changes

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




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