Vitamin A Status With Maize FeedingNCT01814891
Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
A study testing Orange maize feeding, Vitamin A supplement and Oil only in people with Vitamin A Status With Maize Feeding, run by University of Wisconsin, Madison.
Trial summary
Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize. Read more about this study
- Who is it for?
- Ages 57 to 88 monthsHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Status With Maize Feeding
- What is being tested?
- Orange maize feeding, Vitamin A supplement and Oil only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 143 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Oct 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 57 to 88 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 57-88 months at the time of initiation of the study
- Children living in the locality defined by the study and not enrolled in school.
- Consent from parent/guardian.
Who cannot join
- Severely malnourished children (weight for age or height z-scores <-3 standard deviations below the WHO growth reference standards)
- Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
- Children whose families plan to leave the study area before completion of the study
- Consent not obtained from parent/guardian
- Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
- Children with severe anemia (Hb <7.0 g/dL) as determined at the baseline blood draw.
About this study
Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.
Read the detailed description
This study will determine the change in total body stores of vitamin A in response to feeding orange maize for 90 days. This will be compared to two other groups of children that are fed white maize, one of which will get a vitamin A supplement at the estimated average requirement.
- Conditions
- Vitamin A Status With Maize Feeding
- Being tested
- Orange maize feeding, Vitamin A supplement, Oil only
- Keywords
- vitamin A, maize, total body reserves, Condition is vitamin A status., Focus: change in vitamin A status with maize feeding., Focus: feeding orange maize to children for 90 days., Focus: total body reserves of vitamin A.
- Medical subject headings
- Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orange maize feedingOther
This group was fed orange maize.
Vitamin A supplementOther
This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.
Oil onlyOther
This group received a small amount of plain oil without vitamin A.
| Study group | Role | What they receive |
|---|---|---|
| Orange maize | Experimental | Children were fed orange maize and the intervention name was "orange" Receives: Other: Orange maize feeding |
| Blue vitamin A group | Active comparator | Received vitamin A in the form of retinyl palmitate in oil at the estimated average requirment. Receives: Other: Vitamin A supplement |
| White | Placebo comparator | Received oil only at the same volume as the vitamin A group Receives: Other: Oil only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A status changes
Vitamin A status is measured before and after the intervention.
Measured: After the intervention, which is approximately 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startMay 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Vitamin A Status With Maize FeedingStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01814891
- Sponsor's protocol ID
- Zambia II
- Status last verified
- Mar 2013
- First submitted
- 7 Mar 2013
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Sheftel J, Valentine AR, Hull AK, Fadjarwati T, Gannon BM, Davis CR, Tanumihardjo SA. Findings in 3 clinical trials challenge the accuracy of the Institute of Medicine's estimated average requirements for vitamin A in children and women. Am J Clin Nutr. 2021 May 8;113(5):1322-1331. doi: 10.1093/ajcn/nqaa132.
PubMed 32492125Tanumihardjo SA, Gannon BM, Kaliwile C, Chileshe J, Binkley NC. Restricting vitamin A intake increases bone formation in Zambian children with high liver stores of vitamin. Arch Osteoporos. 2019 Jun 28;14(1):72. doi: 10.1007/s11657-019-0617-y.
PubMed 31254130Titcomb TJ, Schmaelzle ST, Nuss ET, Gregory JF 3rd, Tanumihardjo SA. Suboptimal Vitamin B Intakes of Zambian Preschool Children: Evaluation of 24-Hour Dietary Recalls. Food Nutr Bull. 2018 Jun;39(2):281-289. doi: 10.1177/0379572118760373. Epub 2018 Mar 11.
PubMed 29528727Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.
PubMed 26447158Mondloch S, Gannon BM, Davis CR, Chileshe J, Kaliwile C, Masi C, Rios-Avila L, Gregory JF 3rd, Tanumihardjo SA. High provitamin A carotenoid serum concentrations, elevated retinyl esters, and saturated retinol-binding protein in Zambian preschool children are consistent with the presence of high liver vitamin A stores. Am J Clin Nutr. 2015 Aug;102(2):497-504. doi: 10.3945/ajcn.115.112383. Epub 2015 Jul 15.
PubMed 26178727Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.
PubMed 25411289
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Changes in Total Body Stores of Vitamin A in Response to Orange Maize Consumption by Zambian Children
- ClinicalTrials.gov ID
- NCT01814891
- Acronym / sponsor ID
- Zambia II
- Conditions
- Vitamin A Status With Maize Feeding
- Keywords
- vitamin A, maize, total body reserves, Condition is vitamin A status., Focus: change in vitamin A status with maize feeding., Focus: feeding orange maize to children for 90 days., Focus: total body reserves of vitamin A.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 20 Mar 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.
Determination of liver stores of vitamin A will be determined before and after consumption of high pro-vitamin A orange maize, compared to low provitamin A white maize.
Detailed description
This study will determine the change in total body stores of vitamin A in response to feeding orange maize for 90 days. This will be compared to two other groups of children that are fed white maize, one of which will get a vitamin A supplement at the estimated average requirement.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Orange maize | Experimental | Other: Orange maize feedingChildren were fed orange maize and the intervention name was "orange" |
| Blue vitamin A group | Active comparator | Other: Vitamin A supplementReceived vitamin A in the form of retinyl palmitate in oil at the estimated average requirment. |
| White | Placebo comparator | Other: Oil onlyReceived oil only at the same volume as the vitamin A group |
Who may qualify
- Ages
- 57 to 88 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 57-88 months at the time of initiation of the study
- Children living in the locality defined by the study and not enrolled in school.
- Consent from parent/guardian.
Key exclusion criteria (6 listed)
- Severely malnourished children (weight for age or height z-scores <-3 standard deviations below the WHO growth reference standards)
- Children found to be below 57 months and still holding an under five card or above 88 months at the time of initiation of the study or enrolled in school, based on verification of birth dates at screening
- Children whose families plan to leave the study area before completion of the study
- Consent not obtained from parent/guardian
- Children suffering from diarrhea at the time of initiation of the study or with high fever, based on the report of symptoms by the parent/guardian
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 |
|---|---|---|
| Orange maize feedingThis group was fed orange maize. | Other | Orange maize |
| Vitamin A supplementThis group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention. | Other | Blue vitamin A group |
| Oil onlyThis group received a small amount of plain oil without vitamin A. | Other | White |
Primary outcome
Vitamin A status changes
Time frame: After the intervention, which is approximately 3 months.
Vitamin A status is measured before and after the intervention.
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 20 Mar 2013.
- Derived from this study: PubMed 32492125Sheftel J, Valentine AR, Hull AK, Fadjarwati T, Gannon BM, Davis CR, Tanumihardjo SA. Findings in 3 clinical trials challenge the accuracy of the Institute of Medicine's estimated average requirements for vitamin A in children and women. Am J Clin Nutr. 2021 May 8;113(5):1322-1331. doi: 10.1093/ajcn/nqaa132.
- Derived from this study: PubMed 31254130Tanumihardjo SA, Gannon BM, Kaliwile C, Chileshe J, Binkley NC. Restricting vitamin A intake increases bone formation in Zambian children with high liver stores of vitamin. Arch Osteoporos. 2019 Jun 28;14(1):72. doi: 10.1007/s11657-019-0617-y.
- Derived from this study: PubMed 29528727Titcomb TJ, Schmaelzle ST, Nuss ET, Gregory JF 3rd, Tanumihardjo SA. Suboptimal Vitamin B Intakes of Zambian Preschool Children: Evaluation of 24-Hour Dietary Recalls. Food Nutr Bull. 2018 Jun;39(2):281-289. doi: 10.1177/0379572118760373. Epub 2018 Mar 11.
- Derived from this study: PubMed 26447158Suri DJ, Tanumihardjo JP, Gannon BM, Pinkaew S, Kaliwile C, Chileshe J, Tanumihardjo SA. Serum retinol concentrations demonstrate high specificity after correcting for inflammation but questionable sensitivity compared with liver stores calculated from isotope dilution in determining vitamin A deficiency in Thai and Zambian children. Am J Clin Nutr. 2015 Nov;102(5):1259-65. doi: 10.3945/ajcn.115.113050. Epub 2015 Oct 7.
- Derived from this study: PubMed 26178727Mondloch S, Gannon BM, Davis CR, Chileshe J, Kaliwile C, Masi C, Rios-Avila L, Gregory JF 3rd, Tanumihardjo SA. High provitamin A carotenoid serum concentrations, elevated retinyl esters, and saturated retinol-binding protein in Zambian preschool children are consistent with the presence of high liver vitamin A stores. Am J Clin Nutr. 2015 Aug;102(2):497-504. doi: 10.3945/ajcn.115.112383. Epub 2015 Jul 15.
- Derived from this study: PubMed 25411289Gannon B, Kaliwile C, Arscott SA, Schmaelzle S, Chileshe J, Kalungwana N, Mosonda M, Pixley K, Masi C, Tanumihardjo SA. Biofortified orange maize is as efficacious as a vitamin A supplement in Zambian children even in the presence of high liver reserves of vitamin A: a community-based, randomized placebo-controlled trial. Am J Clin Nutr. 2014 Dec;100(6):1541-50. doi: 10.3945/ajcn.114.087379. Epub 2014 Oct 8.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Orange maize feeding, Vitamin A supplement and Oil only in people with Vitamin A Status With Maize Feeding, run by University of Wisconsin, Madison.
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 3 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 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Vitamin A status changes (time frame: After the intervention, which is approximately 3 months.). 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 NCT01814891, which also lists 6 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 20 Mar 2013.