MalnutritionNCT01541696
Exchangeable Zinc Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants /Toddlers
An observational study of Malnutrition, run by Aga Khan University at 1 site in Pakistan.
Trial summary
The broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. Read more about this study
- Who is it for?
- Ages 9 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants between the ages of 9 and 12 months
Who may be able to join
- Healthy Infants between the ages of 9 and 12 months and on weaning diet for at least 3 months.
- Infants who are currently recruited in the main zinc gates study and consuming sprinkles sachet containing micronutrient and zinc .
Who cannot join
- Infants with congenital anomalies
- Infants not on weaning diet
- Infants not consuming sprinkles sachet containing micronutrients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
The broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the proposed study will measure the amount of zinc absorbed from a test meal of typical unfortified complementary foods consumed by Pakistani infants, or the same complementary foods fortified by the addition of the Zn-containing Sprinkle.
Read the detailed description
In the nested study we aim to measure from a subgroup of recruited children in the main study, the amount of zinc absorbed from typical unfortified complementary foods consumed by Pakistani infants, and compare it with the same complementary food fortified by the addition of the Zn-containing Sprinkles and multi vitamins. Since EZP Exchangeable Zinc Pool is considered to be the gold standard for estimation of the actual concentration of zinc in the plasma that is readily available for cellular function, we would also calculate the EZP in this subset of samples.
The specific aim of the nested study will :
- Determine absorption of zinc (Zn) from a test meal consisting of typical local food with addition of a multiple-micronutrient Sprinkles product containing (10 mg of Zn) vs absorption from the same meal without zinc supplementation to those with no micronutrient fortification.
- Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) with control group.
- Children will be followed for growth monitoring for at least 2 years.
- Plasma zinc and phytates levels in the weaning diet will also be assessed.
- Conditions
- Malnutrition
- Keywords
- zinc, zn, EZP (exchangeable zinc pools)multivitamin MN
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group B | subjects in this group will receive Micronutrient Supplements only. | |
| Group C | Subjects in this Group will receive Micronutrient Supplements plus Zinc. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) .
Compare plasma zinc levels between the two groups Measure the fractional absorption of zinc between the two groups
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, International Atomic Energy Agency, Bill and Melinda Gates Foundation
- Responsible party
- Principal investigator, Dr Shabina Ariff, Aga Khan University
- Investigators
- Sajid B Soofi, MBBS, FCPS, Principal investigator, Aga Khan UniversityShabina Ariff, MBBS, FCPS, Study director, Aga Khan UniversityZulfiqar A Bhutta, PhD, Study chair, Aga Khan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541696
- Sponsor's protocol ID
- 1387-PED-ERC-09
- Status last verified
- Jun 2018
- First submitted
- 11 Jan 2012
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exchangeable Zn Pool Size and Zn Absorption From Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
- ClinicalTrials.gov ID
- NCT01541696
- Acronym / sponsor ID
- 1387-PED-ERC-09
- Conditions
- Malnutrition
- Keywords
- zinc, zn, EZP (exchangeable zinc pools)multivitamin MN
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, International Atomic Energy Agency, Bill and Melinda Gates Foundation
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 1 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The broad objective is to improve zinc status in older infants and young children who are at risk of zinc deficiency because of combination of inadequate dietary zinc intake and high rates of diarrhea. As a sub-study within larger RCT using zinc fortified Sprinkles, the proposed study will measure the amount of zinc absorbed from a test meal of typical unfortified complementary foods consumed by Pakistani infants, or the same complementary foods fortified by the addition of the Zn-containing Sprinkle.
Detailed description
In the nested study we aim to measure from a subgroup of recruited children in the main study, the amount of zinc absorbed from typical unfortified complementary foods consumed by Pakistani infants, and compare it with the same complementary food fortified by the addition of the Zn-containing Sprinkles and multi vitamins. Since EZP Exchangeable Zinc Pool is considered to be the gold standard for estimation of the actual concentration of zinc in the plasma that is readily available for cellular function, we would also calculate the EZP in this subset of samples.
The specific aim of the nested study will :
- Determine absorption of zinc (Zn) from a test meal consisting of typical local food with addition of a multiple-micronutrient Sprinkles product containing (10 mg of Zn) vs absorption from the same meal without zinc supplementation to those with no micronutrient fortification.
- Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) with control group.
- Children will be followed for growth monitoring for at least 2 years.
- Plasma zinc and phytates levels in the weaning diet will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | – | –subjects in this group will receive Micronutrient Supplements only. |
| Group C | – | –Subjects in this Group will receive Micronutrient Supplements plus Zinc. |
Who may qualify
- Ages
- 9 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants between the ages of 9 and 12 months
Key inclusion criteria (2 listed)
- Healthy Infants between the ages of 9 and 12 months and on weaning diet for at least 3 months.
- Infants who are currently recruited in the main zinc gates study and consuming sprinkles sachet containing micronutrient and zinc .
Key exclusion criteria (3 listed)
- Infants with congenital anomalies
- Infants not on weaning diet
- Infants not consuming sprinkles sachet containing micronutrients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers
Time frame: one year
Compare size of exchangeable Zn pool (EZP) for subjects who have been randomized to receive multi-micronutrient Sprinkle (MN) only with those who were randomized to (MN+Zn ) . Compare plasma zinc levels between the two groups Measure the fractional absorption of zinc between the two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajid B Soofi, MBBS, FCPS principal investigator
Aga Khan University
Shabina Ariff, MBBS, FCPS study director
Aga Khan University
Zulfiqar A Bhutta, PhD study chair
Aga Khan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malnutrition, run by Aga Khan University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exchangeable Zn Pool Size and Zn Absorption from Sprinkles and Traditional Foods in Pakistani Infants/Toddlers (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.