NCT01506648

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

January 9, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

November 28, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

January 9, 2012

Last Update Submit

November 25, 2016

Conditions

Bioavailability

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age12 Months - 24 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability 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

You may qualify if:

  • month old
  • Male of female
  • Height and weight between -2.0 SD and +2.0 SD with respect to WHO child growth standards.
  • No mineral and vitamin supplements 2 weeks prior to the study and during the whole duration of the study

You may not qualify if:

  • Body temperature ≥ 37.5°C
  • Hemoglobin ≤ 7g/dL
  • Positive RDT test
  • Any metabolic, gastrointestinal or chronic disease (according to the statement of the subject's parent) known chronic diseases at the gastrointestinal tract)
  • Long term mediation (that may affect zinc metabolism) during the whole study to interact with zinc metabolism (such as kidney diseases or

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU-Yalgado Ouédraogo, Service Pédiatrie

Ouagadougou, Burkina Faso

Location

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

January 9, 2012

First Posted

January 10, 2012

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

November 28, 2016

Record last verified: 2016-11

Locations

BU(1)