Nutritional DeficiencyNCT01783067
Zinc and Iron Bioavailability From Biofortified Pearl Millet
A study testing Pearl millet and Biofortified pearl millet in people with Nutritional Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
Trial summary
Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Read more about this study
- Who is it for?
- Ages 18 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- Pearl millet and Biofortified pearl millet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Feb 2011to Jan 2012
- Phase
- Interventional
- 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 18 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- lives in one of the targeted communities
- apparently healthy
- 23 m of age [may need modification]
- Hemoglobin (Hb) > 8 g/dl
- ferritin ≤ 12mg/L
Who cannot join
- Hemoglobin (Hb) < 8g/dl
- serum ferritin > 12 (even after correction for C-reactive protein (CRP)/ Alpha Glyco Protein (AGP)
- thalassemia
- birth weight < 2,500 g
- birth defect affecting growth and development
- chronic infection
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
University of Colorado Denver
Aurora, Colorado, 80045
About this study
Official title: Zinc and Iron Bioavailability From Bio-fortified Pearl Millet
Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.
Read the detailed description
Nutritional deficiency of iron in 30-70% of young children in different communities in India is well documented and has proved challenging to eradicate both in India and globally. Less is known about zinc deficiency, but zinc and iron are generally present in the same foods and there is also growing evidence for the public health importance of zinc deficiency in young children on a global basis. In populations that depend primarily on plant-based foods, biofortification of major food staples by traditional selective plant breeding procedures offers an attractive strategy for preventing iron and zinc deficiency in all age groups. Pearl millet, a major food staple in several areas of India, has both naturally relatively high concentrations of iron and zinc with demonstrated potential to increase these levels further with plant breeding. Before embarking on complex, costly efficacy, effectiveness studies of the potential health benefits of this biofortified grain, the objective of this project is to determine the extent to which iron and zinc absorption is increased in very young children who consume pearl millet as the primary grain and major food staple. This is a short term, cross-sectional double-blinded study in which the test or control pearl millet is fed for a total of 9 days. Primary outcome measures are the increases in iron and zinc absorption over a two-day period. Test meals will be labeled with a zinc stable isotope on Day 8 and an iron stable isotope on Days 8 and 9 during which days participants and their mothers will stay in their community health center. Food intake will be weighed and duplicate diets obtained. Percentage iron absorption will be determined from erythrocyte enrichment on Day 23. Fractional zinc absorption will be measured from urine enrichment with orally and intravenously administered zinc isotopes from timed samples collected on Days 12-15. Daily absorption of these minerals will be determined. Increases in intake and absorption of these minerals (mg/d) will be evaluated with respect to estimated dietary and physiologic requirements.
- Conditions
- Nutritional Deficiency
- Being tested
- Pearl millet, Biofortified pearl millet
- Keywords
- Biofortification, Pearl millet, Iron absorption, Zinc absorption
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pearl milletOther
Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.
Biofortified pearl milletOther
Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.
| Study group | Role | What they receive |
|---|---|---|
| Iron and zinc biofortified pearl millet | Experimental | Participants in the experimental arm consume pearl millet which has been biofortified with iron and zinc. Receives: Other: Biofortified pearl millet |
| Pearl millet | Active comparator | Participants in the control arm consume non-biofortified pearl millet. Receives: Other: Pearl millet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absorption of iron from pearl millet
Absorption of iron will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of iron for two days will be measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).
Measured: 2 days
Absorption of zinc from pearl millet
Absorption of zinc will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of zinc for a day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2013 (estimated)
- Study startFeb 2011
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Nutritional DeficiencyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, HarvestPlus, International Atomic Energy Agency
- Responsible party
- Sponsor
- Investigators
- Michael Hambidge, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01783067
- Sponsor's protocol ID
- 13-1430
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2013
- Last updated
- 28 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Kodkany BS, Bellad RM, Mahantshetti NS, Westcott JE, Krebs NF, Kemp JF, Hambidge KM. Biofortification of pearl millet with iron and zinc in a randomized controlled trial increases absorption of these minerals above physiologic requirements in young children. J Nutr. 2013 Sep;143(9):1489-93. doi: 10.3945/jn.113.176677. Epub 2013 Jul 10.
PubMed 23843474Miller LV, Hambidge KM, Krebs NF. Zinc Absorption Is Not Related to Dietary Phytate Intake in Infants and Young Children Based on Modeling Combined Data from Multiple Studies. J Nutr. 2015 Aug;145(8):1763-9. doi: 10.3945/jn.115.213074. Epub 2015 Jun 24.
PubMed 26108545
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zinc and Iron Bioavailability From Bio-fortified Pearl Millet
- ClinicalTrials.gov ID
- NCT01783067
- Acronym / sponsor ID
- 13-1430
- Conditions
- Nutritional Deficiency
- Keywords
- Biofortification, Pearl millet, Iron absorption, Zinc absorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Jawaharlal Nehru Medical College, HarvestPlus, International Atomic Energy Agency
- Study start
- Feb 2011
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 4 Feb 2013 (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.
Populations who consume non-fortified plant-based diets are at increased risk of iron and zinc deficiencies. The purpose of this randomized controlled study is to determine the absorption of iron and zinc from pearl millet biofortified with these two micronutrients. Forty children aged 2 years in Kanartaka, India are randomized to consume biofortified pearl millet (Group 1) or control pearl millet (Group 2) for two days. Quantities of zinc and iron absorbed are measured with established stable isotope extrinsic labeling techniques and analyses of duplicate diets.
Detailed description
Nutritional deficiency of iron in 30-70% of young children in different communities in India is well documented and has proved challenging to eradicate both in India and globally. Less is known about zinc deficiency, but zinc and iron are generally present in the same foods and there is also growing evidence for the public health importance of zinc deficiency in young children on a global basis. In populations that depend primarily on plant-based foods, biofortification of major food staples by traditional selective plant breeding procedures offers an attractive strategy for preventing iron and zinc deficiency in all age groups. Pearl millet, a major food staple in several areas of India, has both naturally relatively high concentrations of iron and zinc with demonstrated potential to increase these levels further with plant breeding. Before embarking on complex, costly efficacy, effectiveness studies of the potential health benefits of this biofortified grain, the objective of this project is to determine the extent to which iron and zinc absorption is increased in very young children who consume pearl millet as the primary grain and major food staple. This is a short term, cross-sectional double-blinded study in which the test or control pearl millet is fed for a total of 9 days. Primary outcome measures are the increases in iron and zinc absorption over a two-day period. Test meals will be labeled with a zinc stable isotope on Day 8 and an iron stable isotope on Days 8 and 9 during which days participants and their mothers will stay in their community health center. Food intake will be weighed and duplicate diets obtained. Percentage iron absorption will be determined from erythrocyte enrichment on Day 23. Fractional zinc absorption will be measured from urine enrichment with orally and intravenously administered zinc isotopes from timed samples collected on Days 12-15. Daily absorption of these minerals will be determined. Increases in intake and absorption of these minerals (mg/d) will be evaluated with respect to estimated dietary and physiologic requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron and zinc biofortified pearl millet | Experimental | Other: Biofortified pearl milletParticipants in the experimental arm consume pearl millet which has been biofortified with iron and zinc. |
| Pearl millet | Active comparator | Other: Pearl milletParticipants in the control arm consume non-biofortified pearl millet. |
Who may qualify
- Ages
- 18 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- lives in one of the targeted communities
- apparently healthy
- 23 m of age [may need modification]
- Hemoglobin (Hb) > 8 g/dl
- ferritin ≤ 12mg/L
Key exclusion criteria (6 listed)
- Hemoglobin (Hb) < 8g/dl
- serum ferritin > 12 (even after correction for C-reactive protein (CRP)/ Alpha Glyco Protein (AGP)
- thalassemia
- birth weight < 2,500 g
- birth defect affecting growth and development
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pearl milletParticipants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days. | Other | Pearl millet |
| Biofortified pearl milletParticipants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days. | Other | Iron and zinc biofortified pearl millet |
Primary outcome
Absorption of iron from pearl millet
Time frame: 2 days
Absorption of iron will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of iron for two days will be measured by extrinsic labeling with stable isotopes of iron and measuring erythrocyte enrichment. Measurement of total iron in duplicate diets on test days will allow determination of quantity of this micronutrient absorbed (mg/d).
Absorption of zinc from pearl millet
Time frame: 1 day
Absorption of zinc will be measured while the participants are eating pearl millet as their major food staple which will provide at least 50% energy and at least 75% iron, zinc and phytate of the diet. Fractional absorption of zinc for a day will be measured by extrinsic labeling with stable isotopes of zinc. Fractional absorption of zinc will be measured by a dual isotope tracer ratio technique. Measurement of total zinc in duplicate diets on test day will allow determination of quantity of this micronutrient absorbed (mg/d).
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 28 Apr 2016.
- Background: PubMed 23843474Kodkany BS, Bellad RM, Mahantshetti NS, Westcott JE, Krebs NF, Kemp JF, Hambidge KM. Biofortification of pearl millet with iron and zinc in a randomized controlled trial increases absorption of these minerals above physiologic requirements in young children. J Nutr. 2013 Sep;143(9):1489-93. doi: 10.3945/jn.113.176677. Epub 2013 Jul 10.
- Background: PubMed 26108545Miller LV, Hambidge KM, Krebs NF. Zinc Absorption Is Not Related to Dietary Phytate Intake in Infants and Young Children Based on Modeling Combined Data from Multiple Studies. J Nutr. 2015 Aug;145(8):1763-9. doi: 10.3945/jn.115.213074. Epub 2015 Jun 24.
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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.
Michael Hambidge, MD principal investigator
University of Colorado, Denver
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pearl millet and Biofortified pearl millet in people with Nutritional Deficiency, run by University of Colorado, Denver at 2 sites in 2 countries.
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 5 inclusion and 6 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 28 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, India. 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?
Absorption of iron from pearl millet (time frame: 2 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01783067, which also lists 2 linked publications.
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 28 Apr 2016.