MalnutritionvitapoolNCT01751009
Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
A study testing Vitamin A supplements and Sprinkles without Vitamin A in people with Malnutrition, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
Trial summary
This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period. Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Malnutrition
- What is being tested?
- Vitamin A supplements and Sprinkles without Vitamin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteGhana
- Study dates
- Jan 2010to Jun 2010
- 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 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Informed consent of mother of eligible children aged 6-12 months.
- Willingness to remain in the study area for entire duration of the study.
- Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.
- The child should have started taking complementary foods in addition to breast milk.
- Child's haemoglobin level of at least 70 g/L.
Who cannot join
- Child's haemoglobin level less than 70 g/L.
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.
Read the detailed description
The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.
- Conditions
- Malnutrition
- Being tested
- Vitamin A supplements, Sprinkles without Vitamin A
- Keywords
- vitamin A, complementary foods, malnutrition, children
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin A supplementsDietary supplement
Sprinkles with Vitamin A
Sprinkles without Vitamin ADietary supplement
Active comparator
| Study group | Role | What they receive |
|---|---|---|
| Vitamin A supplements | Experimental | Sprinkles with Vitamin A Receives: Dietary Supplement: Vitamin A supplements |
| Sprinkles without Vitamin A | Active comparator | Made of other micronutrients without Vitamin A Receives: Dietary Supplement: Sprinkles without Vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vitamin A status after 5 months supplementation
Measured: 5 months
Secondary outcomes (1)
acceptability of home based fortified vitamin A supplements
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2012 (estimated)
- Study startJan 2010
- Primary completionJun 2010
- Study completionJun 2010
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
- 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kintampo Health Research Centre, Ghana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Responsible party
- Sponsor
- Investigators
- Sherry Tanumihardjo, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01751009
- Sponsor's protocol ID
- IORG0004854
- Acronym
- vitapool
- Status last verified
- Dec 2012
- First submitted
- 5 Nov 2012
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Home-based Trial of the Effects of Fortified Complementary Foods on Vitamin A Status and Body Pool Size in Ghanaian Infants.
- ClinicalTrials.gov ID
- NCT01751009
- Acronym / sponsor ID
- vitapool / IORG0004854
- Conditions
- Malnutrition
- Keywords
- vitamin A, complementary foods, malnutrition, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Kintampo Health Research Centre, GhanaUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison
- Study start
- Jan 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 17 Dec 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.
This study tried to prove that children given food supplements containing vitamin A would have better liver vitamin A stores than children given food supplements without vitamin A over a 5 month period.
Detailed description
The study wanted to assess the effect of fortification of home based complementary foods on vitamin A status in Ghanaian children who receive food supplements known as Sprinkles. The study assessed the vitamin A status and body pool size in children using a test known as the modified relative dose response test (MRDR) tests and stable 13C2 retinol as a tracer, among those who receive Sprinkles with or without vitamin A through home fortification of complementary foods.
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 |
|---|---|---|
| Vitamin A supplements | Experimental | Dietary Supplement: Vitamin A supplementsSprinkles with Vitamin A |
| Sprinkles without Vitamin A | Active comparator | Dietary Supplement: Sprinkles without Vitamin AMade of other micronutrients without Vitamin A |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Informed consent of mother of eligible children aged 6-12 months.
- Willingness to remain in the study area for entire duration of the study.
- Willingness to agree to feed the child with supplied micronutrient supplements for duration of study.
- The child should have started taking complementary foods in addition to breast milk.
- Child's haemoglobin level of at least 70 g/L.
Key exclusion criteria (2 listed)
- Child's haemoglobin level less than 70 g/L.
- Unable to give informed consent
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 |
|---|---|---|
| Vitamin A supplementsSprinkles with Vitamin A | Dietary supplement | Vitamin A supplements |
| Sprinkles without Vitamin AActive comparator | Dietary supplement | Sprinkles without Vitamin A |
Primary outcome
Vitamin A status after 5 months supplementation
Time frame: 5 months
1 secondary outcome
acceptability of home based fortified vitamin A supplements
Time frame: 5 months
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 17 Dec 2012.
- Related InfoLink provided by the sponsor.
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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.
Sherry Tanumihardjo, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin A supplements and Sprinkles without Vitamin A in people with Malnutrition, run by Kintampo Health Research Centre, Ghana at 1 site in Ghana.
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 2 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 17 Dec 2012. 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 Ghana. 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?
Vitamin A status after 5 months supplementation (time frame: 5 months). 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 17 Dec 2012.