Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000429
Status:
COMPLETED
Last Update Posted:
2013-08-01
First Post:
2000-01-18
Brief Title:
Calcium Supplements for Bone Health in Juvenile Rheumatoid Arthritis
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Calcium Supplementation for Bone Mineralization in Juvenile Rheumatoid Arthritis JRA
Status:
COMPLETED
Status Verified Date:
2013-07
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 looks at the effects of taking calcium pills on bone health in young people with juvenile rheumatoid arthritis JRA In this 2-year study children aged 6-18 who have JRA will take either a calcium supplement or a matching placebo inactive or dummy pill containing no calcium During the study researchers and patients will not know if a patient is taking calcium or placebo We believe that patients who take calcium supplements will have at least a 10 percent greater increase in total body bone mineral density compared to patients who take the placebo
We will evaluate patients at Childrens Hospital Medical Center every 6 months for 2 years During this 2-year period participants in the study will take one multivitamin containing 400 IU international units of vitamin D and either 1000 mg of calcium carbonate Tums tablets by mouth or a matching placebo once a day We will check patients 6 and 18 months after the 2-year treatment period to find out if people in the Tums-treated group maintain any increases in bone formation that occurred during the 2-year treatment period
We will evaluate patients at Childrens Hospital Medical Center every 6 months for 2 years During this 2-year period participants in the study will take one multivitamin containing 400 IU international units of vitamin D and either 1000 mg of calcium carbonate Tums tablets by mouth or a matching placebo once a day We will check patients 6 and 18 months after the 2-year treatment period to find out if people in the Tums-treated group maintain any increases in bone formation that occurred during the 2-year treatment period
Detailed Description:
This is a randomized double-blind placebo-controlled trial of 24 months in which juvenile rheumatoid arthritis JRA patients will take either an oral calcium supplement of 1000 mg elemental calcium per day or a matching placebo containing no calcium Ca plus one multivitamin per day We hypothesize that patients receiving calcium supplementation will demonstrate at least a 10 percent greater increase in total body bone mineral density compared to those treated with placebo
We will evaluate patients at Childrens Hospital Medical Center CHMC every 6 months for 2 years We will also evaluate patients 6 and 18 months after the end of the intervention period to determine the persistence of any demonstrated increased bone mineralization in the Tums-treated group The study requires analysis of human blood and urine samples and low-dose radiation exposure
We have randomized 193 JRA patients equally into two treatment groups active and placebo The active treatment group is taking in a single daily dose two 500 mg tablets of elemental Ca as CaC03 calcium carbonate and one multivitamin tablet containing 400 IU vitamin D The placebo treatment group is taking in a single daily dose two placebo tablets matched on size appearance and taste containing 0 mg elemental Ca and one multivitamin tablet containing 400 IU vitamin D We do all patient evaluations in the Clinical Research Center at Childrens Hospital Medical Center
Every 6 months during the 2-year intervention trial we will perform interval history general and joint physical exam anthropometric measurements height weight BMI pill counts MMEM monitor check DXA scan of total body and lumbar spine for bone mineral density and dispensing of study drugs At yearly intervals during the intervention trial we will do the YouthAdolescent Questionnaire YAQ on diet which is validated for 1-year recall 3-day diet diary for current intake blood tests for mineral and calcitropic hormone concentrations 24-hour urine for measurements of bone turnover markers and mineral excretion physical function assessment JAFAR and physical activity questionnaire We will obtain blood for determining vitamin D receptor VDR genotype at baseline only We will perform fasting random urine tests to determine Cacreatinine ratio to assess for treatment-induced hypercalciuria at months 0 3 6 12 18 and 24
Monthly during the intervention trial the study coordinator will contact all participants by phone in a blinded fashion to increase compliance and encourage continued participation in the trial We will evaluate participants 6 and 18 moths after the end of the intervention trial At each of these visits we will obtain the following general and medication history general and joint physical exam Tanner Stage anthropometric measurements blood for minerals and calcitropic hormones 24-hour urine collection for measurements of bone turnover markers and mineral excretion JAFAR physical activity questionnaire and total body and lumbar spine DXA scans The YAQ and 3-day diet diary will be completed at the 42-month visit Prior to every DXA scan we will do a urine pregnancy test in all menstruating females to ensure that they are not pregnant Any patient who withdraws from the blinded portion of the study early will complete an evaluation as outlined for the 24 months visit Patients who withdraw early during the open phase of the study will complete the 42 months evaluation
We will exclude from the study people who have recently taken systemic corticosteroids people taking oral contraceptives smokers and pregnant women because these factors have been shown to significantly lower bone mineralization We will withdraw subjects from the study if they demonstrate an elevated fasting random urinary calciumcreatinine ratio 02 a chronic disease in addition to JRA that affects growth or bone mineralization or they become pregnant We will include these patients and all those withdrawing from the study voluntarily in an intention-to-treat analysis
We will evaluate patients at Childrens Hospital Medical Center CHMC every 6 months for 2 years We will also evaluate patients 6 and 18 months after the end of the intervention period to determine the persistence of any demonstrated increased bone mineralization in the Tums-treated group The study requires analysis of human blood and urine samples and low-dose radiation exposure
We have randomized 193 JRA patients equally into two treatment groups active and placebo The active treatment group is taking in a single daily dose two 500 mg tablets of elemental Ca as CaC03 calcium carbonate and one multivitamin tablet containing 400 IU vitamin D The placebo treatment group is taking in a single daily dose two placebo tablets matched on size appearance and taste containing 0 mg elemental Ca and one multivitamin tablet containing 400 IU vitamin D We do all patient evaluations in the Clinical Research Center at Childrens Hospital Medical Center
Every 6 months during the 2-year intervention trial we will perform interval history general and joint physical exam anthropometric measurements height weight BMI pill counts MMEM monitor check DXA scan of total body and lumbar spine for bone mineral density and dispensing of study drugs At yearly intervals during the intervention trial we will do the YouthAdolescent Questionnaire YAQ on diet which is validated for 1-year recall 3-day diet diary for current intake blood tests for mineral and calcitropic hormone concentrations 24-hour urine for measurements of bone turnover markers and mineral excretion physical function assessment JAFAR and physical activity questionnaire We will obtain blood for determining vitamin D receptor VDR genotype at baseline only We will perform fasting random urine tests to determine Cacreatinine ratio to assess for treatment-induced hypercalciuria at months 0 3 6 12 18 and 24
Monthly during the intervention trial the study coordinator will contact all participants by phone in a blinded fashion to increase compliance and encourage continued participation in the trial We will evaluate participants 6 and 18 moths after the end of the intervention trial At each of these visits we will obtain the following general and medication history general and joint physical exam Tanner Stage anthropometric measurements blood for minerals and calcitropic hormones 24-hour urine collection for measurements of bone turnover markers and mineral excretion JAFAR physical activity questionnaire and total body and lumbar spine DXA scans The YAQ and 3-day diet diary will be completed at the 42-month visit Prior to every DXA scan we will do a urine pregnancy test in all menstruating females to ensure that they are not pregnant Any patient who withdraws from the blinded portion of the study early will complete an evaluation as outlined for the 24 months visit Patients who withdraw early during the open phase of the study will complete the 42 months evaluation
We will exclude from the study people who have recently taken systemic corticosteroids people taking oral contraceptives smokers and pregnant women because these factors have been shown to significantly lower bone mineralization We will withdraw subjects from the study if they demonstrate an elevated fasting random urinary calciumcreatinine ratio 02 a chronic disease in addition to JRA that affects growth or bone mineralization or they become pregnant We will include these patients and all those withdrawing from the study voluntarily in an intention-to-treat analysis
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 |
|---|---|---|---|
| NIAMS-020 | US NIH GrantContract | None | httpsreporternihgovquickSearchP60AR044059 |
| P60AR044059 | NIH | None | None |