Text Size

Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Michael B. Zimmermann, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier:
NCT01506648
First received: January 9, 2012
Last updated: June 6, 2013
Last verified: June 2013
History of Changes
  Purpose

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


Condition
Study Not Related to a Disease. Nutrition Study Without Drug Administration.

Study Type: Observational
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

Further study details as provided by Swiss Federal Institute of Technology:

Primary Outcome Measures:
  • Fractional absorption of zinc [ Time Frame: 33 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 40
Study Start Date: January 2011
Study Completion Date: October 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   12 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Study not related to a disease. Nutrition study without drug drug administration. 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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01506648

Locations
Burkina Faso
CHU-Yalgado Ouédraogo, Service Pédiatrie
Ouagadougou, Burkina Faso
Sponsors and Collaborators
Swiss Federal Institute of Technology
  More Information

No publications provided

Responsible Party: Prof. Michael B. Zimmermann, Prof, Swiss Federal Institute of Technology
ClinicalTrials.gov Identifier: NCT01506648     History of Changes
Other Study ID Numbers: INSTAPA-FP7-211484
Study First Received: January 9, 2012
Last Updated: June 6, 2013
Health Authority: Switzerland: Ethics Committee of ETH Zurich
Burkina Faso: Ethics Committee of Burkina Faso
Burkina Faso: General Direction of the Pharmacy, Medicines and Laboratories (DGPML)
Burkina Faso: Ministry of Health

ClinicalTrials.gov processed this record on June 17, 2013