We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessment of Zinc Absorption From a Phytic Acid Rich Complementary Food

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01506648
Recruitment Status : Completed
First Posted : January 10, 2012
Last Update Posted : November 28, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
Bioavailability

Study Design

Study Type : Observational
Actual Enrollment : 40 participants
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
Study Start Date : January 2011
Primary Completion Date : April 2012
Study Completion Date : October 2012
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Fractional absorption of zinc [ Time Frame: 33 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506648


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

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
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: November 28, 2016
Last Verified: November 2016