Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472654
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2007-05-10
Brief Title:
The Effect of Vitamin D Supplementation During Caloric Restriction on Intestinal Calcium Absorption
Sponsor:
Rutgers University
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Nutritional Regulation of Bone - Aim 3
Status:
COMPLETED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 25OHD 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 25OHD 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 vitaminmineral 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
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 vitaminmineral 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01AG012161 | NIH | None | None |
| AG012161 | US NIH GrantContract | None | httpsreporternihgovquickSearchR01AG012161 |