Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00352170
Status:
COMPLETED
Last Update Posted:
2008-08-11
First Post:
2006-07-12
Brief Title:
Calcium and Vitamin D Malnutrition in Elderly Women
Sponsor:
Creighton University
Organization:
Creighton University
Study Overview
Official Title:
Calcium and Vitamin D Malnutrition in Elderly Women
Status:
COMPLETED
Status Verified Date:
2008-08
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:
This study is designed to test whether calcium supplementation alone or calcium plus vitamin D reduces the incidence of fractures reduces high parathyroid secretory activity and halts bone loss in a population-based sample of women 55 years of age
A calcium supplement of 1400 mgd will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living rural women 55 years of age and older compared to similar women on their usual diets
A calcium supplement of 1400 mgd plus 1100 IU vitamin Dd will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only
A calcium supplement of 1400 mgd will significantly reduce the cumulative incidence of spine and appendicular fractures over four years for independently living rural women 55 years of age and older compared to similar women on their usual diets
A calcium supplement of 1400 mgd plus 1100 IU vitamin Dd will significantly reduce the cumulative incidence of spine and appendicular fractures compared to a calcium supplement only
Detailed Description:
We are conducting a 4-year randomized double-blind placebo controlled trial of calcium or calcium with vitamin D supplementation We randomly sampled the population of healthy independent living women 55 years in nine rural counties We randomly assigned 1180 women to one of three groups Group 1 receives calcium 1400 mgd and vitamin D placebo Group 2 receives both calcium 1400 mgd and vitamin D 1100 IUd and Group 3 receives both placebos
A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation The participants were enrolled into study between May 2000 and July 2001
Participants have study visits every six months Annually the following are performed bone density scans height and weight brief medical history including medicine changes fracture surveillance and compliance with calcium and vitamin D At baseline and end of study spine x-rays and dietary recall were obtained
A full-service market research firm randomly selected telephone numbers from all households with listed numbers in the nine-county rural sample area The firm continued calling until 1180 women were selected who met the inclusion and exclusion criteria and were willing to participate in a four year prospective study of calcium and vitamin D supplementation The participants were enrolled into study between May 2000 and July 2001
Participants have study visits every six months Annually the following are performed bone density scans height and weight brief medical history including medicine changes fracture surveillance and compliance with calcium and vitamin D At baseline and end of study spine x-rays and dietary recall were obtained
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