Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040456
Status:
TERMINATED
Last Update Posted:
2012-11-19
First Post:
2002-06-26
Brief Title:
Oral Magnesium Pidolate Hemoglobin SC Disease MG Pidolate
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
The Effect of Oral Magnesium Pidolate on Incidence of Painful Crises in Patients With Hemoglobin SC Disease
Status:
TERMINATED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Subjects have a form of sickle cell disease called hemoglobin SC disease This results in abnormally shaped red blood cells that get stuck in blood vessels and then results in episodes of severe pain pain crises Patients with the more common form of sickle cell disease called hemoglobin SS disease also suffer from pain crises Treatment with the drug hydroxyurea is available to help prevent the pain crises in hemoglobin SS disease but there is no good treatment to help prevent the pain crises in hemoglobin SC disease
It has been shown that one of the reasons for the formation of the abnormally shaped red blood cells in patients with SC disease is the fact that these cells do not contain enough water they are dehydrated Drinking more water will not increase the amount of water in the cells Certain salts and minerals can however have an effect on the amount of water in the red blood cells One of the most important minerals influencing this is called magnesium Magnesium is present in food and also in certain medications used to treat heartburn Magnesium has been used successfully both in animals and people to increase the amount of water in the red blood cells and is very well tolerated by most people
Investigators are using a new form of magnesium known as magnesium pidolate because this form of magnesium may help with the symptoms of disease without causing diarrhea a common side effect of magnesium products
Purpose The purpose of this study is to find out whether treatment with magnesium pidolate will increase the amount of water in the red blood cell and result in fewer painful crises in patients with hemoglobin SC disease while not causing diarrhea
The study will last for about 64 weeks about 16 months
It has been shown that one of the reasons for the formation of the abnormally shaped red blood cells in patients with SC disease is the fact that these cells do not contain enough water they are dehydrated Drinking more water will not increase the amount of water in the cells Certain salts and minerals can however have an effect on the amount of water in the red blood cells One of the most important minerals influencing this is called magnesium Magnesium is present in food and also in certain medications used to treat heartburn Magnesium has been used successfully both in animals and people to increase the amount of water in the red blood cells and is very well tolerated by most people
Investigators are using a new form of magnesium known as magnesium pidolate because this form of magnesium may help with the symptoms of disease without causing diarrhea a common side effect of magnesium products
Purpose The purpose of this study is to find out whether treatment with magnesium pidolate will increase the amount of water in the red blood cell and result in fewer painful crises in patients with hemoglobin SC disease while not causing diarrhea
The study will last for about 64 weeks about 16 months
Detailed Description:
This is a placebo-controlled study which means that the effectiveness of the magnesium medication the chemical form of which is known as Mg pidolate will be compared to placebo A placebo looks like the drug that is being studied in this case magnesium but does not contain any active drug of any kind Comparing magnesium with placebo will help decide whether magnesium is better than treatment with placebo
The study lasts for 64 weeks about 16 months and is divided into 2 parts each part lasting for 32 weeks 8 months During the first part study medication magnesium or placebo will be taken twice daily for 24 weeks about 6 months followed by no study medication for 8 weeks These 8 weeks are called a washout period during which time the effects of the study medication are washed-out of the body After the washout 8 weeks patients will enter the second part of the study During this second part the study medication magnesium or placebo will again be taken twice daily for 24 weeks During the second part of the study participants will receive whichever study medication that was not taken during the first part of the study Following the second 24 weeks there will be an observation period of 8 weeks during which time no study medication is taken The study is completed at the end of the 8-week observation period Participants will take magnesium for 24 weeks and placebo for 24 weeks The decision whether participants will receive magnesium or placebo first will be made randomly by a computer This is a double-blind study which means that neither the participant nor the study doctor will know which study medication is taking during each part of the study However the study may be unblinded for safety issues if necessary
If the participant responds to the study medication it can be continued after completion of the 24 weeks
The study medication is in the form of a liquid taken two times a day morning and evening with the actual amount taken depending on the participants weight
During this study the participant will be seen in clinic on a regular basis initially every 2 weeks later once a month There will be a total of 21 clinic visits during the study Three of these are clinic visits that would normally take place in the routine management of this disease The other 18 visits are required for this study At each visit participants will have blood tests to measure the amount of magnesium in the blood especially the red blood cells but also to look for any other changes that might occur The total amount of blood collected during the 16 month study is 120 ml 24 teaspoons which is a safe amount Three ml half teaspoon will be drawn at 13 visits 5ml 1 teaspoon at 4 visits and 15ml 3 teaspoons at a further 4 visits At 4 of the clinic visits a urine test will be performed
During the study participants will be asked to keep a record of all episodes of pain or any other changes that are noticed in the form of a diary
The study lasts for 64 weeks about 16 months and is divided into 2 parts each part lasting for 32 weeks 8 months During the first part study medication magnesium or placebo will be taken twice daily for 24 weeks about 6 months followed by no study medication for 8 weeks These 8 weeks are called a washout period during which time the effects of the study medication are washed-out of the body After the washout 8 weeks patients will enter the second part of the study During this second part the study medication magnesium or placebo will again be taken twice daily for 24 weeks During the second part of the study participants will receive whichever study medication that was not taken during the first part of the study Following the second 24 weeks there will be an observation period of 8 weeks during which time no study medication is taken The study is completed at the end of the 8-week observation period Participants will take magnesium for 24 weeks and placebo for 24 weeks The decision whether participants will receive magnesium or placebo first will be made randomly by a computer This is a double-blind study which means that neither the participant nor the study doctor will know which study medication is taking during each part of the study However the study may be unblinded for safety issues if necessary
If the participant responds to the study medication it can be continued after completion of the 24 weeks
The study medication is in the form of a liquid taken two times a day morning and evening with the actual amount taken depending on the participants weight
During this study the participant will be seen in clinic on a regular basis initially every 2 weeks later once a month There will be a total of 21 clinic visits during the study Three of these are clinic visits that would normally take place in the routine management of this disease The other 18 visits are required for this study At each visit participants will have blood tests to measure the amount of magnesium in the blood especially the red blood cells but also to look for any other changes that might occur The total amount of blood collected during the 16 month study is 120 ml 24 teaspoons which is a safe amount Three ml half teaspoon will be drawn at 13 visits 5ml 1 teaspoon at 4 visits and 15ml 3 teaspoons at a further 4 visits At 4 of the clinic visits a urine test will be performed
During the study participants will be asked to keep a record of all episodes of pain or any other changes that are noticed in the form of a diary
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 |
|---|---|---|---|
| MG Pidolate | OTHER | Baylor College of Medicine | None |