Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06618365
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-09-08
Brief Title:
Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Oral or Intra Muscular Vitamin D2 Vs Oral or Intra Muscular Vitamin D3 in Treatment of Vitamin D Deficiency
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or IM vitamin D2 The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level
Detailed Description:
In a systemic review it was found that treating individuals who have vitamin D deficiency with vitamin D3 rather than vitamin D2 would be a better option Vitamin D3 is superior in treating Vitamin D deficiency according to this systemic review However this systemic review raised a question of comparing oral to IM treatment of vitamin D deficiency and no Data was available to support either treatment above the other
The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or IM vitamin D2 The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level
The research will involve 100 patients between the age of 20-50 years old They will be divided into 4 groups Each group will have either oral or IM vitamin D2 or oral or IM vitamin D3 The oral doses will be 50000 international units to be taken weekly and the IM doses will be of 300000 international units which will be taken once every 6 weeks Vitamin D level will be checked once every 4 weeks The initial expected duration of the first phase of the research will be about 6-12 weeks which will give us a good orientation to answer the main and the second questions Then the follow up may take up to another 6 months to check the maintenance dose of the best recommended oral or IM treatment of bolus doses in certain intervals as initial trial
The main purpose of this research is to find out if there is any difference between treating vitamin D deficiency with oral vitamin D3 or IM vitamin D2 The second aim of this research is to confirm the superiority of Vitamin D3 over Vitamin D2 in treating vitamin D deficiency Additional useful information in this research is to find out the best recommended maintenance dose of vitamin D and formula by having regular follow up of treated individuals once their serum vitamin D level reach the recommended normal serum level
The research will involve 100 patients between the age of 20-50 years old They will be divided into 4 groups Each group will have either oral or IM vitamin D2 or oral or IM vitamin D3 The oral doses will be 50000 international units to be taken weekly and the IM doses will be of 300000 international units which will be taken once every 6 weeks Vitamin D level will be checked once every 4 weeks The initial expected duration of the first phase of the research will be about 6-12 weeks which will give us a good orientation to answer the main and the second questions Then the follow up may take up to another 6 months to check the maintenance dose of the best recommended oral or IM treatment of bolus doses in certain intervals as initial trial
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