Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
9 May 2016 |
Main ID: |
NCT02208635 |
Date of registration:
|
01/08/2014 |
Prospective Registration:
|
No |
Primary sponsor: |
|
Public title:
|
Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months
HPZM |
Scientific title:
|
Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months |
Date of first enrolment:
|
October 2012 |
Target sample size:
|
60 |
Recruitment status: |
Completed |
URL:
|
https://clinicaltrials.gov/show/NCT02208635 |
Study type:
|
Interventional |
Study design:
|
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|
Phase:
|
N/A
|
|
Countries of recruitment
|
United States
|
Zambia
| | | | | | |
Contacts
|
Name:
|
Michael Hambidge, MD |
Address:
|
|
Telephone:
|
|
Email:
|
|
Affiliation:
|
University of Colorado, Denver |
| | |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Children age 24 to 36 months
- Maize meal accounts for at least 75% energy intake
- Able to consume 100 g maize flour/day
- Clinically healthy (stunting is acceptable)
- Lives in target community
Exclusion Criteria:
- Children with chronic or other known chronic disease
- If children are receiving zinc-fortified products, these products will need to be
withheld for 2 weeks prior to the study
Age minimum:
24 Months
Age maximum:
36 Months
Gender:
Both
|
Health Condition(s) or Problem(s) studied
|
Nutritional Deficiency
|
Intervention(s)
|
Other: Biofortified Maize
|
Other: Fortified Maize
|
Other: Control Maize
|
Primary Outcome(s)
|
Absorption of zinc
[Time Frame: 1 day]
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|