World Health Organization site
Skip Navigation Links

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: University of Colorado, Denver
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]
Secondary Outcome(s)
Secondary ID(s)
14-1126
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
University Teaching Hospital, Lusaka, Zambia
HarvestPlus
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history