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

Primary Purpose

Weight Loss, Vitamin D or Placebo

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weight Loss
Vitamin D 2500 IU
Weight Maintenance
Sponsored by
Rutgers University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Weight Loss focused on measuring bone mass, calcium absorption, bone quality, fracture risk

Eligibility Criteria

50 Years - 72 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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 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)

Sites / Locations

  • Rutgers University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Placebo Comparator

Active Comparator

Arm Label

WL

WL + D

WM

WM + D

Arm Description

Outcomes

Primary Outcome Measures

Changes in Calcium absorption

Secondary Outcome Measures

Changes in serum and urine bone markers, hormones, glucose, proteins and genes

Full Information

First Posted
May 10, 2007
Last Updated
March 27, 2023
Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT00472654
Brief Title
The Effect of Vitamin D Supplementation During Caloric Restriction on Intestinal Calcium Absorption
Official Title
Nutritional Regulation of Bone - Aim 3
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers University
Collaborators
National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).
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 2500 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 2500 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss, Vitamin D or Placebo
Keywords
bone mass, calcium absorption, bone quality, fracture risk

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WL
Arm Type
Placebo Comparator
Arm Title
WL + D
Arm Type
Experimental
Arm Title
WM
Arm Type
Placebo Comparator
Arm Title
WM + D
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Weight Loss
Intervention Description
Diet for weight loss for 6 weeks; all weight loss participants will attend 6 weekly counseling sessions (about 50 minutes per session)
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D 2500 IU
Intervention Description
Daily Vitamin D 2500 IU supplement for 6 weeks
Intervention Type
Behavioral
Intervention Name(s)
Weight Maintenance
Intervention Description
Diet for weight maintenance for 6 weeks
Primary Outcome Measure Information:
Title
Changes in Calcium absorption
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Changes in serum and urine bone markers, hormones, glucose, proteins and genes
Time Frame
6 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
72 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sue Shapses, PhD
Organizational Affiliation
Rutgers University, Nutritional Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16702302
Citation
Shapses SA, Riedt CS. Bone, body weight, and weight reduction: what are the concerns? J Nutr. 2006 Jun;136(6):1453-6. doi: 10.1093/jn/136.6.1453.
Results Reference
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PubMed Identifier
15746990
Citation
Riedt CS, Cifuentes M, Stahl T, Chowdhury HA, Schlussel Y, Shapses SA. Overweight postmenopausal women lose bone with moderate weight reduction and 1 g/day calcium intake. J Bone Miner Res. 2005 Mar;20(3):455-63. doi: 10.1359/JBMR.041132. Epub 2004 Nov 29.
Results Reference
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PubMed Identifier
15213038
Citation
Cifuentes M, Riedt CS, Brolin RE, Field MP, Sherrell RM, Shapses SA. Weight loss and calcium intake influence calcium absorption in overweight postmenopausal women. Am J Clin Nutr. 2004 Jul;80(1):123-30. doi: 10.1093/ajcn/80.1.123. Erratum In: Am J Clin Nutr. 2005 Jan;81(1):199.
Results Reference
background
PubMed Identifier
14742841
Citation
Goode LR, Brolin RE, Chowdhury HA, Shapses SA. Bone and gastric bypass surgery: effects of dietary calcium and vitamin D. Obes Res. 2004 Jan;12(1):40-7. doi: 10.1038/oby.2004.7.
Results Reference
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PubMed Identifier
22282301
Citation
Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Brolin RE, Taich L. Hormonal and dietary influences on true fractional calcium absorption in women: role of obesity. Osteoporos Int. 2012 Nov;23(11):2607-14. doi: 10.1007/s00198-012-1901-5. Epub 2012 Jan 27.
Results Reference
background
PubMed Identifier
23364004
Citation
Shapses SA, Sukumar D, Schneider SH, Schlussel Y, Sherrell RM, Field MP, Ambia-Sobhan H. Vitamin D supplementation and calcium absorption during caloric restriction: a randomized double-blind trial. Am J Clin Nutr. 2013 Mar;97(3):637-45. doi: 10.3945/ajcn.112.044909. Epub 2013 Jan 30.
Results Reference
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The Effect of Vitamin D Supplementation During Caloric Restriction on Intestinal Calcium Absorption

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