Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

Bioavailability Clinical Trial

Official title:

Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food, Consumed by Young Children Immediately After the Addition of the Enzyme Phytase. A Randomized Single Blind Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506648
• Other study ID #: INSTAPA-FP7-211484
• Status: Completed
• Phase: N/A
• First received: January 9, 2012
• Last updated: November 25, 2016
• Start date: January 2011
• Est. completion date: October 2012

Study information

• Verified date: November 2016
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethics Committee of ETH ZurichBurkina Faso: Ethics Committee of Burkina FasoBurkina Faso: General Direction of the Pharmacy, Medicines and Laboratories (DGPML)Burkina Faso: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Assessment of zinc absorption from a phytic acid rich complementary food, consumed by young children immediately after the addition of the enzyme phytase. A randomized single blind study

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 24 Months

Eligibility

Inclusion Criteria:

1. 12-24 month old

2. Male of female

3. Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.

4. No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study

Exclusion Criteria:

1. Body temperature = 37.5°C

2. Hemoglobin = 7g/dL

3. Positive RDT test

4. Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)

5. Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or

Study Design

N/A

Related Conditions & MeSH terms

• Bioavailability

Locations

Country	Name	City	State
Burkina Faso	CHU-Yalgado Ouédraogo, Service Pédiatrie	Ouagadougou

Sponsors (1)

Lead Sponsor	Collaborator
Swiss Federal Institute of Technology

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fractional absorption of zinc	Fractional absorption of zinc is estimated by using the double isotope tracer ratio technique by administering 67Zn as oral and 70Zn as intravenous stable isotopes.The urinary enrichment with both isotopes is measured in a spot urine sample by inductively coupled plasma mass spectrometry.	33 days	No