Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122941
Status:
COMPLETED
Last Update Posted:
2008-06-16
First Post:
2005-07-21
Brief Title:
Effect of Multiple Micronutrient Supplementation on Growth Morbidity and Mortality of HIV Infected Children in Uganda
Sponsor:
Makerere University
Organization:
Makerere University
Study Overview
Official Title:
Effect of Multiple Micronutrient Supplementation on Growth Morbidity and Mortality of HIV Infected Children in Uganda a Randomised Double Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2008-06
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:
MMS
Brief Summary:
Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition especially in poor resource countries such as Uganda It appears that micronutrient deficiencies contribute to immune dysfunction increased morbidity and HIV disease progression Hitherto there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa Therefore the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda
Hypothesis Daily administration of twice the recommended dietary allowance 2RDA of multiple micronutrients to HIV infected children aged one to five years for 6 months will reduce all cause mortality from 24 to 144 in one year and result in a weight gain difference of 150 grams
Hypothesis Daily administration of twice the recommended dietary allowance 2RDA of multiple micronutrients to HIV infected children aged one to five years for 6 months will reduce all cause mortality from 24 to 144 in one year and result in a weight gain difference of 150 grams
Detailed Description:
Micronutrient deficiencies are common in HIV infected children and are aggravated by poor nutrition especially in poor resource countries such as Uganda It appears that micronutrient deficiencies contribute to immune dysfunction increased morbidity and HIV disease progression Hitherto there has been no randomised controlled trial to assess the effect of multiple micronutrient supplementation on morbidity and mortality in HIV infected children in Africa Therefore the investigators shall carry out a randomised controlled trial to determine the effect of multiple micronutrient supplementation on morbidity weight gain and mortality among HIV infected children aged 1 to 5 years in Uganda
Hypothesis Daily administration of twice the recommended dietary allowance 2RDA of multiple micronutrients to HIV infected children aged one to five years for 6 months will reduce all cause mortality from 24 to 144 in one year and result in a weight gain difference of 150 grams
A sample size of 373 was calculated assuming that the mortality risk in one year in HIV infected children is 24 Barhane et al and that this risk will be reduced to 144 in the intervention group 40 effect size with 90 power and 95 confidence
Assuming a 10 attrition rate 38 study participants the final sample size in each group is 411
Hypothesis Daily administration of twice the recommended dietary allowance 2RDA of multiple micronutrients to HIV infected children aged one to five years for 6 months will reduce all cause mortality from 24 to 144 in one year and result in a weight gain difference of 150 grams
A sample size of 373 was calculated assuming that the mortality risk in one year in HIV infected children is 24 Barhane et al and that this risk will be reduced to 144 in the intervention group 40 effect size with 90 power and 95 confidence
Assuming a 10 attrition rate 38 study participants the final sample size in each group is 411
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 |
|---|---|---|---|
| MV910 | None | None | None |