Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers
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| First Received Date ICMJE | January 11, 2012 | ||||||||||||
| Last Updated Date | March 6, 2012 | ||||||||||||
| Start Date ICMJE | June 2010 | ||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers [ Time Frame: one year ] [ Designated as safety issue: No ] Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) . Compare plasma zinc levels between the two groups Measure the fractional absorption of zinc between the two groups |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01541696 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers | ||||||||||||
| Official Title ICMJE | Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers | ||||||||||||
| Brief Summary | The broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the proposed study will measure the amount of zinc absorbed from a test meal of typical unfortified complementary foods consumed by Pakistani infants, or the same complementary foods fortified by the addition of the Zn-containing Sprinkle. |
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| Detailed Description | In the nested study we aim to measure from a subgroup of recruited children in the main study, the amount of zinc absorbed from typical unfortified complementary foods consumed by Pakistani infants, and compare it with the same complementary food fortified by the addition of the Zn-containing Sprinkles and multi vitamins. Since EZP Exchangeable Zinc Pool is considered to be the gold standard for estimation of the actual concentration of zinc in the plasma that is readily available for cellular function, we would also calculate the EZP in this subset of samples. The specific aim of the nested study will :
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| Study Type ICMJE | Observational | ||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||
| Biospecimen | Not Provided | ||||||||||||
| Sampling Method | Probability Sample | ||||||||||||
| Study Population | Infants between the ages of 9 and 12 months |
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| Condition ICMJE | Malnutrition | ||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||||||
| Enrollment ICMJE | 40 | ||||||||||||
| Estimated Completion Date | June 2012 | ||||||||||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 9 Months to 12 Months | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Pakistan | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01541696 | ||||||||||||
| Other Study ID Numbers ICMJE | 1387-PED-ERC-09 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | Dr Shabina Ariff, Aga Khan University | ||||||||||||
| Study Sponsor ICMJE | Aga Khan University | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Aga Khan University | ||||||||||||
| Verification Date | March 2012 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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