Vitamin A DeficiencyNCT01922713
Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women
A study testing white maize and a corn oil capsule, orange maize and a corn oil capsule and white maize and a vitamin A capsule in people with Vitamin A Deficiency, run by University of California, Davis at 1 site in Zambia.
Trial summary
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Vitamin A Deficiency
- What is being tested?
- white maize and a corn oil capsule, orange maize and a corn oil capsule and white maize and a vitamin A capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 1 siteZambia
- Study dates
- Oct 2013to Dec 2014
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy lactating women 18-35 years of age
- who are breastfeeding a single infant, 4-12 mo of age.
Who cannot join
- Pregnancy,
- Chronic disease,
- Hb concentration <90 g/L,
- Signs or symptoms of vitamin A deficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.
Read the detailed description
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
- Conditions
- Vitamin A Deficiency
- Being tested
- white maize and a corn oil capsule, orange maize and a corn oil capsule, white maize and a vitamin A capsule
- Keywords
- biofortification, vitamin A, maize, beta-carotene, breastmilk, Zambia
- Medical subject headings
- Vitamin A Deficiency, Callosities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
white maize and a corn oil capsuleOther
~ 0 ug RAE/d
orange maize and a corn oil capsuleOther
Also called beta-carotene biofortified maize
~600 ug RAE/d
white maize and a vitamin A capsuleOther
Also called retinyl palmitate capsule
600 ug RAE/d
| Study group | Role | What they receive |
|---|---|---|
| white maize | Placebo comparator | white maize and a corn oil capsule Receives: Other: white maize and a corn oil capsule |
| orange maize | Experimental | orange maize and a corn oil capsule Receives: Other: orange maize and a corn oil capsule |
| vitamin A | Active comparator | white maize and a vitamin A capsule Receives: Other: white maize and a vitamin A capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk retinol concentration
Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)
Measured: After 3 weeks of intervention
Secondary outcomes (1)
Breastmilk beta-carotene concentration
Breastmilk beta-carotene concentration will be measured before and after 3 wk of consumption of orange maize (6d/wk)
Measured: After 3 wk of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vitamin A DeficiencyStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, Tropical Diseases Research Centre, Zambia
- Responsible party
- Sponsor
- Investigators
- Marjorie Haskell, PhD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01922713
- Sponsor's protocol ID
- HP-8282
- Status last verified
- Jan 2015
- First submitted
- 12 Aug 2013
- Last updated
- 26 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Palmer AC, Chileshe J, Hall AG, Barffour MA, Molobeka N, West KP Jr, Haskell MJ. Short-Term Daily Consumption of Provitamin A Carotenoid-Biofortified Maize Has Limited Impact on Breast Milk Retinol Concentrations in Zambian Women Enrolled in a Randomized Controlled Feeding Trial. J Nutr. 2016 Sep;146(9):1783-92. doi: 10.3945/jn.116.233700. Epub 2016 Jul 27.
PubMed 27466608
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
- ClinicalTrials.gov ID
- NCT01922713
- Acronym / sponsor ID
- HP-8282
- Conditions
- Vitamin A Deficiency
- Keywords
- biofortification, vitamin A, maize, beta-carotene, breastmilk, Zambia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Johns Hopkins University, Tropical Diseases Research Centre, Zambia
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Aug 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.
The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.
Detailed description
Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received ~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| white maize | Placebo comparator | Other: white maize and a corn oil capsulewhite maize and a corn oil capsule |
| orange maize | Experimental | Other: orange maize and a corn oil capsuleorange maize and a corn oil capsule |
| vitamin A | Active comparator | Other: white maize and a vitamin A capsulewhite maize and a vitamin A capsule |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Apparently healthy lactating women 18-35 years of age
- who are breastfeeding a single infant, 4-12 mo of age.
Key exclusion criteria (4 listed)
- Pregnancy,
- Chronic disease,
- Hb concentration <90 g/L,
- Signs or symptoms of vitamin A deficiency
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 |
|---|---|---|
| white maize and a corn oil capsule~ 0 ug RAE/d | Other | white maize |
| orange maize and a corn oil capsuleAlso: beta-carotene biofortified maize~600 ug RAE/d | Other | orange maize |
| white maize and a vitamin A capsuleAlso: retinyl palmitate capsule600 ug RAE/d | Other | vitamin A |
Primary outcome
Breast milk retinol concentration
Time frame: After 3 weeks of intervention
Breast milk retinol concentration will be measured before and after 3 wk of consumption of orange maize (6 d/wk)
1 secondary outcome
Breastmilk beta-carotene concentration
Time frame: After 3 wk of 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 26 Jan 2015.
- Derived from this study: PubMed 27466608Palmer AC, Chileshe J, Hall AG, Barffour MA, Molobeka N, West KP Jr, Haskell MJ. Short-Term Daily Consumption of Provitamin A Carotenoid-Biofortified Maize Has Limited Impact on Breast Milk Retinol Concentrations in Zambian Women Enrolled in a Randomized Controlled Feeding Trial. J Nutr. 2016 Sep;146(9):1783-92. doi: 10.3945/jn.116.233700. Epub 2016 Jul 27.
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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.
Marjorie Haskell, PhD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing white maize and a corn oil capsule, orange maize and a corn oil capsule and white maize and a vitamin A capsule in people with Vitamin A Deficiency, run by University of California, Davis at 1 site in Zambia.
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 4 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 26 Jan 2015. 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 Zambia. 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. 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?
Breast milk retinol concentration (time frame: After 3 weeks of intervention). 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 NCT01922713, which also lists 1 linked publication.
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 26 Jan 2015.