HypovitaminosisPhase 2/3NCT00742937
Impact of Maternal Supplementation With Dual Megadose of Vitamin A
A Phase 2/3 study testing vitamin A in people with Hypovitaminosis and Vitamin A Deficiency, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
Trial summary
The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypovitaminosis, Vitamin A Deficiency
- What is being tested?
- vitamin A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2007to Dec 2008
- Phase
- Phase 2/3
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant low-risk obstetric
Who cannot join
- Premature birth
- Newborn babies with birth defects and / or other serious diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Materno Infantil Prof. Fernando Figueira
Recife, Pernambuco
About this study
Official title: Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
The purpose of this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.
Read the detailed description
The effect will be assessed by the milk and blood.
- Conditions
- Hypovitaminosis, Vitamin A Deficiency
- Being tested
- vitamin A, Placebo
- Keywords
- Hypovitaminosis A
- Medical subject headings
- Avitaminosis, Vitamin A Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin ADietary supplement
second capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery.
PlaceboDietary supplement
second capsule with vitamin E, eight days after delivery.
| Study group | Role | What they receive |
|---|---|---|
| A | Placebo comparator | After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of vitamin E will be administer. Receives: Dietary Supplement: Placebo |
| B | Experimental | After birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of 200,000 UI of retinol palmitate (vitamin A)plus vitamin E will be administer. Receives: Dietary Supplement: vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seric retinol
Measured: six months
Secondary outcomes (1)
Morbidity and growth of the child.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2008 (estimated)
- Study startJul 2007
- Primary completionAug 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HypovitaminosisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando Figueira
- Sponsor type
- University, hospital or other
- Investigators
- Ilma Kruze, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00742937
- Sponsor's protocol ID
- IMIPVITA-001
- Status last verified
- Jul 2009
- First submitted
- 26 Aug 2008
- Last updated
- 29 Jul 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tomiya MT, de Arruda IK, da Silva Diniz A, Santana RA, da Silveira KC, Andreto LM. The effect of vitamin A supplementation with 400 000 IU vs 200 000 IU on retinol concentrations in the breast milk: A randomized clinical trial. Clin Nutr. 2017 Feb;36(1):100-106. doi: 10.1016/j.clnu.2015.11.018. Epub 2015 Dec 17.
PubMed 26725194Dos Santos CS, Kruze I, Fernandes T, Andreto LM, Figueiroa JN, Diniz Ada S. The Effect of a Maternal Double Megadose of Vitamin A Supplement on Serum Levels of Retinol in Children Aged under Six Months. J Nutr Metab. 2013;2013:876308. doi: 10.1155/2013/876308. Epub 2013 Dec 24.
PubMed 24455219Fernandes TF, Figueiroa JN, Grande de Arruda IK, Diniz Ada S. Effect on infant illness of maternal supplementation with 400 000 IU vs 200 000 IU of vitamin A. Pediatrics. 2012 Apr;129(4):e960-6. doi: 10.1542/peds.2011-0119. Epub 2012 Mar 12.
PubMed 22412025
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Supplementation With Dual Megadose of Vitamin A in the Post-partum About Vitamin A Levels in Breast Milk, Serum Levels of Vitamin A and Iron in the Binomial Mother-son and Growth and Morbidity of Children Under 6 Months
- ClinicalTrials.gov ID
- NCT00742937
- Acronym / sponsor ID
- IMIPVITA-001
- Conditions
- Hypovitaminosis, Vitamin A Deficiency
- Keywords
- Hypovitaminosis A
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Instituto Materno Infantil Prof. Fernando FigueiraUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Aug 2008 (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 this study is to evaluate the effect of maternal supplementation with 400,000 IU of oral retinol palmitate in the post-partum, the nutritional situation of the binomial mother-child, on growth and morbidity of children in breastfeeding in the first six months of life.
Detailed description
The effect will be assessed by the milk and blood.
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 |
|---|---|---|
| A | Placebo comparator | Dietary Supplement: PlaceboAfter birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of vitamin E will be administer. |
| B | Experimental | Dietary Supplement: vitamin AAfter birth the women will receive one capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E and eight days after delivery the second capsule of 200,000 UI of retinol palmitate (vitamin A)plus vitamin E will be administer. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant low-risk obstetric
Key exclusion criteria (2 listed)
- Premature birth
- Newborn babies with birth defects and / or other serious diseases
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 Asecond capsule 200,000 UI of retinol palmitate (vitamin A)plus vitamin E, eight days after delivery. | Dietary supplement | B |
| Placebosecond capsule with vitamin E, eight days after delivery. | Dietary supplement | A |
Primary outcome
Seric retinol
Time frame: six months
1 secondary outcome
Morbidity and growth of the child.
Time frame: six 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 29 Jul 2009.
- Derived from this study: PubMed 26725194Tomiya MT, de Arruda IK, da Silva Diniz A, Santana RA, da Silveira KC, Andreto LM. The effect of vitamin A supplementation with 400 000 IU vs 200 000 IU on retinol concentrations in the breast milk: A randomized clinical trial. Clin Nutr. 2017 Feb;36(1):100-106. doi: 10.1016/j.clnu.2015.11.018. Epub 2015 Dec 17.
- Derived from this study: PubMed 24455219Dos Santos CS, Kruze I, Fernandes T, Andreto LM, Figueiroa JN, Diniz Ada S. The Effect of a Maternal Double Megadose of Vitamin A Supplement on Serum Levels of Retinol in Children Aged under Six Months. J Nutr Metab. 2013;2013:876308. doi: 10.1155/2013/876308. Epub 2013 Dec 24.
- Derived from this study: PubMed 22412025Fernandes TF, Figueiroa JN, Grande de Arruda IK, Diniz Ada S. Effect on infant illness of maternal supplementation with 400 000 IU vs 200 000 IU of vitamin A. Pediatrics. 2012 Apr;129(4):e960-6. doi: 10.1542/peds.2011-0119. Epub 2012 Mar 12.
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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.
Ilma Kruze, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing vitamin A in people with Hypovitaminosis and Vitamin A Deficiency, run by Instituto Materno Infantil Prof. Fernando Figueira at 1 site in Brazil.
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 1 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 29 Jul 2009. 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 Brazil. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Seric retinol (time frame: six 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 NCT00742937, which also lists 3 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 29 Jul 2009.