Clinical Trial: Oral Magnesium Pidolate, Hemoglobin SC Disease, MG Pidolate

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: The Effect of Oral Magnesium Pidolate on Incidence of Painful Crises in Patients With Hemoglobin SC Disease

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 month

Detailed Summary:

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 com
Sponsor: Baylor College of Medicine

Current Primary Outcome: Evaluation of whether treatment with oral Mg pidolate decreases the number of painful crises. [ Time Frame: 64 weeks ]

The difference in frequency of painful episodes between the 2 treatment modalities will be calculated for each patient. The goal is to decrease the frequency of painful episodes by at least 50%.


Original Primary Outcome:

Current Secondary Outcome:

  • Evaluation of tolerance of long-term treatment with oral Mg pidolate. [ Time Frame: 16 months ]
    Adverse events will be tabulated by body system, severity, and relation to treatment in order to determine tolerance.
  • To find out if treatment with oral Mg pidolate increases the intracellular Mg content of erythrocytes. [ Time Frame: 16 months ]
    mean values will be compared by Wilcoxon signed -rank test or the paired t-test
  • Evaluations of the effect of Mg pidolate therapy on the K-Cl cotransport activity and RBC hydration status [ Time Frame: 16 months ]
    McNemar's test will be used to assess the decrease or increase in K-CL cotransport system activity.


Original Secondary Outcome:

Information By: Baylor College of Medicine

Dates:
Date Received: June 26, 2002
Date Started: January 2001
Date Completion:
Last Updated: November 15, 2012
Last Verified: November 2012