Healthy Women Giving Birth to Singleton InfantsNCT00952640
Making Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and Inflammation
A study testing vitamin A in people with Healthy Women Giving Birth to Singleton Infants, run by Institut de Recherche pour le Developpement at 1 site in Vietnam.
Trial summary
Background: Vitamin A is of utmost importance for health and survival of children. A recent series in The Lancet on maternal and child health put vitamin A deficiency at the top of most important micronutrient deficiencies, responsible for more than 600.000 child deaths/year worldwide. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Healthy Women Giving Birth to Singleton Infants
- What is being tested?
- vitamin A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteVietnam
- Study dates
- Jun 2010to 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 18 to 50 years
- Women only
- Adult
Who may be able to join
- Healthy women giving birth to a singleton infant.
Who cannot join
- Women giving birth to infants weighing < 1500 gram (very low birth weight infant) will be excluded.
- Also excluded will be twin pregnancy, because of different growth patterns of the infants and congenital abnormalities interfering with normal growth.
- Furthermore, women indicating that they are planning not to breast feed their baby will be excluded, as well as women who experience delivery complications which result in prolonged (> 3 days) hospital stay.
- Complications such as eclampsia or excessive blood loss will be registered, but will not be a reason for exclusion per se.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Making Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and Inflammation.
Background:
Vitamin A is of utmost importance for health and survival of children. A recent series in The Lancet on maternal and child health put vitamin A deficiency at the top of most important micronutrient deficiencies, responsible for more than 600.000 child deaths/year worldwide. Vitamin A status of mothers and infants is closely linked. Hence, a mother with vitamin A deficiency cannot give enough vitamin A to her fetus to build stores during the last months of pregnancy, and will also have insufficient amounts of vitamin A in her breast milk, resulting in a high risk for vitamin A deficiency in her newborn infant. The World Health Organization (WHO) has implemented several strategies to fight vitamin A deficiency in mothers and children. One of these is to give women after delivery a high dose vitamin A supplement, to improve vitamin A status of mother and, via breast milk, her infant. Surprisingly however, several recent studies investigating the effect of a high dose vitamin A supplement for mothers directly after birth found no effect on vitamin A status in infants 6 months of age. In contrast, earlier studies in Bangladesh and Indonesia, in which women received a high dose vitamin A supplement somewhere in the first 6 weeks after delivery, reported a large impact on vitamin A status in the infants at 6 mo of age. The WHO recommendation on post-partum vitamin A supplementation was based on these earlier studies from Bangladesh and Indonesia. The more recent studies suggest however that this intervention is not effective, and that millions of women currently receive a high dose vitamin A supplement without clear benefits for vitamin A status in either the women or their children.
Read more
The human body reacts to infection or injury with an inflammatory response, which kicks off with the acute phase response. The acute phase response helps the body to fight the infection. It is characterized by many altered physiological processes, including changed availability of vitamins and minerals. Recently, we found that delivery in itself causes a major acute phase response. We have formed the hypothesis that the acute phase response initiated by delivery prevents the high dose vitamin A supplement given to the mother directly after delivery from being absorbed and from being available for breast milk. If this is true, the current WHO recommendation to give the vitamin A within the first 6 weeks post-partum should be changed to giving the vitamin A 4 - 6 weeks post-partum instead, to allow the acute phase response induced by delivery to fade.
Objective(s) and Hypothesis(es):
The main objective is to improve the effectiveness of the current WHO policy of vitamin A supplementation after delivery to improve vitamin A status and health of mothers and their infants.
Methodology:
In a randomized, placebo-controlled, double-blind trial, 400 women will receive a high dose of vitamin A (200.000 IU) within 6 weeks of delivery, as recommended by WHO. Half of the women will receive the vitamin A directly after delivery (within 3 days, current practice), whereas the other women will receive the vitamin A 6 weeks after delivery. To guarantee blinding, women will receive a placebo capsule if they are not receiving a vitamin A capsule.
Main outcomes will be maternal and infant vitamin A status 6 months post-partum and the time-course of the acute phase response, to establish the optimal time after delivery for the initiation of the vitamin A supplementation.
Secondary outcomes will be the morbidity of the infants during the first 6 months of life and growth performance of the infants at 6 mo of age.
Potential Impact:
The results of this study will enable WHO to improve the effectiveness of the current WHO recommendations concerning post-partum vitamin A supplementation. If our hypothesis is true, postponing the timing of the post-partum vitamin A supplement from directly after delivery to 6 week post-partum, will significantly increased the availability of the supplement for the mother. This will increase the vitamin A status of both mother and infant. Moreover, there are several significant implications for global health policies, with important consequences for infant survival worldwide by reducing morbidity and mortality from infectious diseases during the first 6 months of life. Results of the study will also have important consequences for other micronutrient health programs, such as vitamin A supplementation for children above 6 months of age and iron supplementation in areas with endemic malaria, as these are also subject to the effects of the acute phase response
Read the detailed description
Background. Undernutrition causes over 3.5 million child deaths a year, with vitamin A deficiency alone responsible for almost 0.6 million child deaths per year1. Vitamin A supplementation of children above 6 months of age has been shown to reduce overall mortality by 23%. The effect of vitamin A supplementation in newborns on morbidity and mortality is less clear, with three studies in India, Indonesia and Nepal showing reductions in neonatal mortality of 22%, 64% and 15% respectively, but with 2 other trials in Africa reporting no effect. In view of the expected health benefits of improved vitamin A status of infants, WHO currently recommends that women should receive a high dose (200.000 IU ) of vitamin A within the first 6 weeks postpartum, in order to improve maternal vitamin A status, the vitamin A content of breast milk, and thereby the vitamin A status of their infants. However, several recent trials in which women received 200.000 IU vitamin A directly post-partum, reported no improvement in vitamin A status of either mother or her infant at 6 mo of age, not even after doubling the dose to 400.000 IU. In these studies vitamin A was given within a week of delivery, the current typical practice even though WHO actually states a window of 6 weeks after delivery. In contrast, 2 earlier studies in Bangladesh and Indonesia reported a large impact of post-partum maternal supplementation on vitamin A status in infants at 6 mo of age. In these studies, women received a high dose vitamin A supplement not directly post-partum, but somewhere in the first 6 weeks after delivery. The WHO recommendation on maternal post-partum vitamin A supplementation was based on the effects observed in these earlier studies, but the more recent studies suggest now that this intervention is not effective, and that millions of women are receiving a high dose vitamin A supplement without clear benefits for vitamin A status of either the women or their children. The difference in timing between the earlier studies and the recent studies of giving the vitamin A may hold the key, and we believe we have identified the biological reason why timing of the supplementation could be of the utmost importance: the inflammatory response to delivery.
Delivery induces a considerable physiological inflammatory response, with a distinct acute phase response, of the same magnitude as seen for instance in pulmonary tuberculosis patients. We believe that the lack of effect of the current practice of giving a high dose vitamin A supplement directly post-partum is due to the acute phase response induced by the delivery, and that the intervention would be successful if the supplementation was given after the acute phase response has faded away after 3 - 6 weeks. There is currently no data available on the vitamin A bioavailability in lactating women, but a study in Zambian pre-school children investigated the effectiveness of a high dose vitamin A supplementation campaign in children, and showed that this was only successful in children without inflammation. Children who had signs of inflammation had no increase in vitamin A status. Inflammation and the accompanying acute phase response are also known to affect the availability of other micronutrients besides vitamin A, such as iron and zinc.
Objective(s) and Hypothesis(es):
Hypothesis The acute phase response (APR) induced by delivery reduces vitamin A bioavailability, and interferes with current maternal post-partum high dose vitamin A supplementation programs worldwide.
Objective 1 To determine the effects of the acute phase response on vitamin A bioavailability.
Objective 2 To determine the time course of the acute phase response after delivery.
Overall goal To improve the effectiveness of the current WHO recommendation of post-partum maternal high dose vitamin A supplementation by determining the optimal timing for supplementation in relation to the post-partum APR.
Design and Methods:
A randomised, placebo-controlled, double-blind trial in 400 women, comparing the effects of the recommended dose of 200.000 IU of vitamin A given within the first week post-partum (current practice, 200 women) with the effect when given at 6 weeks post-partum, which is still within the WHO recommended intervention window (200 women). Main outcomes will be maternal and infant vitamin A status 6 months post-partum, breast milk vitamin A concentrations and the time-course of acute phase response, to establish the optimal time after delivery for vitamin A supplementation. Secondary outcomes will be morbidity of the infants during the first 6 months of life and anthropometrical indices of the infants at 6 mo of age.
Potential Impact:
If our hypothesis is true, the current global health strategy of postpartum vitamin A supplementation to improve vitamin A status of mothers and infants can be made effective just by changing the timing. This will have significant implications for global health policies, with important consequences for infant survival worldwide by improving vitamin A status and reducing morbidity and mortality from infectious diseases during the first 6 months of life. Moreover, results of the study will have important consequences for other micronutrient health programs, such as vitamin A supplementation for children above 6 months of age and iron or zinc supplementation programs, as these are also affected by the acute phase response. Overall, the results of this research will contribute to improving child survival worldwide.
- Being tested
- vitamin A
- Keywords
- vitamin A, post-partum, infant, acute phase response
- Medical subject headings
- Acute-Phase Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin ADietary supplement
high dose vitamin A, 200.000 IU
| Study group | Role | What they receive |
|---|---|---|
| vitamin A directly post-partum | Active comparator | 200.000 IU of vitamin A within 3 days of delivery Receives: Dietary Supplement: vitamin A |
| vitamin A delayed | Experimental | 200.000 IU vitamin A 6 weeks post-partum Receives: Dietary Supplement: vitamin A |
What is being measured
The primary outcome is the main question the study is designed to answer.
vitamin A status of lactating women 6 mo post-partum vitamin A status of infants 6 mo of age acute phase proteins concentrations (CRP, AGP) at several time-points during the first 6 mo post-partum
Measured: several times points during the first 6 mo post-partum (different time points for different indicators)
plasma retinol 6 mo post-partum (women and infants), breast milk retinol (6 weeks, 4 mo and 6 mo post-partum), liver retinol stores of infants 6 mo post-partum acute phase proteins, at 2 weeks, 6 weeks, 4 mo and 6 mo post-partum (women)
Measured: 2 and 6 weeks, 4 mo and 6 mo post-partum
Secondary outcomes (1)
morbidity infants during the first 6 mo of life anthropometry at 6 mo post-partum
Measured: 6 mo of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJun 2010
- Primary completionMay 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy Women Giving Birth to Singleton InfantsStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de Recherche pour le Developpement
- Sponsor type
- Other government
- Collaborators
- Thrasher Research Fund, University of Copenhagen, National Institute of Nutrition, Vietnam
- Responsible party
- Principal investigator, Frank Wieringa, Institut de Recherche pour le Developpement
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00952640
- Sponsor's protocol ID
- VitA_PP
- Status last verified
- Oct 2012
- First submitted
- 3 Aug 2009
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Friis H, Range N, Braendgaard Kristensen C, Kaestel P, Changalucha J, Malenganisho W, Krarup H, Magnussen P, Bengaard Andersen A. Acute- phase response and iron status markers among pulmonary tuberculosis patients: a cross-sectional study in Mwanza, Tanzania. Br J Nutr. 2009 Jul;102(2):310-7. doi: 10.1017/S0007114508162122. Epub 2009 Jan 28.
PubMed 19175946Ayah RA, Mwaniki DL, Magnussen P, Tedstone AE, Marshall T, Alusala D, Luoba A, Kaestel P, Michaelsen KF, Friis H. The effects of maternal and infant vitamin A supplementation on vitamin A status: a randomised trial in Kenya. Br J Nutr. 2007 Aug;98(2):422-30. doi: 10.1017/S0007114507705019. Epub 2007 Mar 29.
PubMed 17391562Wieringa FT, Dijkhuizen MA, van der Meer JW. Maternal micronutrient supplementation and child survival. Lancet. 2008 May 24;371(9626):1751-2. doi: 10.1016/S0140-6736(08)60758-8. No abstract available.
PubMed 18502294Dijkhuizen MA, Wieringa FT, West CE, Muhilal. Zinc plus beta-carotene supplementation of pregnant women is superior to beta-carotene supplementation alone in improving vitamin A status in both mothers and infants. Am J Clin Nutr. 2004 Nov;80(5):1299-307. doi: 10.1093/ajcn/80.5.1299.
PubMed 15531679
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Making Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and Inflammation.
- ClinicalTrials.gov ID
- NCT00952640
- Acronym / sponsor ID
- VitA_PP
- Keywords
- vitamin A, post-partum, infant, acute phase response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Institut de Recherche pour le DeveloppementOther government
- Collaborators
- Thrasher Research Fund, University of Copenhagen, National Institute of Nutrition, Vietnam
- Study start
- Jun 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 6 Aug 2009 (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.
Background:
Vitamin A is of utmost importance for health and survival of children. A recent series in The Lancet on maternal and child health put vitamin A deficiency at the top of most important micronutrient deficiencies, responsible for more than 600.000 child deaths/year worldwide. Vitamin A status of mothers and infants is closely linked. Hence, a mother with vitamin A deficiency cannot give enough vitamin A to her fetus to build stores during the last months of pregnancy, and will also have insufficient amounts of vitamin A in her breast milk, resulting in a high risk for vitamin A deficiency in her newborn infant. The World Health Organization (WHO) has implemented several strategies to fight vitamin A deficiency in mothers and children. One of these is to give women after delivery a high dose vitamin A supplement, to improve vitamin A status of mother and, via breast milk, her infant. Surprisingly however, several recent studies investigating the effect of a high dose vitamin A supplement for mothers directly after birth found no effect on vitamin A status in infants 6 months of age. In contrast, earlier studies in Bangladesh and Indonesia, in which women received a high dose vitamin A supplement somewhere in the first 6 weeks after delivery, reported a large impact on vitamin A status in the infants at 6 mo of age. The WHO recommendation on post-partum vitamin A supplementation was based on these earlier studies from Bangladesh and Indonesia. The more recent studies suggest however that this intervention is not effective, and that millions of women currently receive a high dose vitamin A supplement without clear benefits for vitamin A status in either the women or their children.
The human body reacts to infection or injury with an inflammatory response, which kicks off with the acute phase response. The acute phase response helps the body to fight the infection. It is characterized by many altered physiological processes, including changed availability of vitamins and minerals. Recently, we found that delivery in itself causes a major acute phase response. We have formed the hypothesis that the acute phase response initiated by delivery prevents the high dose vitamin A supplement given to the mother directly after delivery from being absorbed and from being available for breast milk. If this is true, the current WHO recommendation to give the vitamin A within the first 6 weeks post-partum should be changed to giving the vitamin A 4 - 6 weeks post-partum instead, to allow the acute phase response induced by delivery to fade.
Objective(s) and Hypothesis(es):
The main objective is to improve the effectiveness of the current WHO policy of vitamin A supplementation after delivery to improve vitamin A status and health of mothers and their infants.
Methodology:
In a randomized, placebo-controlled, double-blind trial, 400 women will receive a high dose of vitamin A (200.000 IU) within 6 weeks of delivery, as recommended by WHO. Half of the women will receive the vitamin A directly after delivery (within 3 days, current practice), whereas the other women will receive the vitamin A 6 weeks after delivery. To guarantee blinding, women will receive a placebo capsule if they are not receiving a vitamin A capsule.
Main outcomes will be maternal and infant vitamin A status 6 months post-partum and the time-course of the acute phase response, to establish the optimal time after delivery for the initiation of the vitamin A supplementation.
Secondary outcomes will be the morbidity of the infants during the first 6 months of life and growth performance of the infants at 6 mo of age.
Potential Impact:
The results of this study will enable WHO to improve the effectiveness of the current WHO recommendations concerning post-partum vitamin A supplementation. If our hypothesis is true, postponing the timing of the post-partum vitamin A supplement from directly after delivery to 6 week post-partum, will significantly increased the availability of the supplement for the mother. This will increase the vitamin A status of both mother and infant. Moreover, there are several significant implications for global health policies, with important consequences for infant survival worldwide by reducing morbidity and mortality from infectious diseases during the first 6 months of life. Results of the study will also have important consequences for other micronutrient health programs, such as vitamin A supplementation for children above 6 months of age and iron supplementation in areas with endemic malaria, as these are also subject to the effects of the acute phase response
Detailed description
Background. Undernutrition causes over 3.5 million child deaths a year, with vitamin A deficiency alone responsible for almost 0.6 million child deaths per year1. Vitamin A supplementation of children above 6 months of age has been shown to reduce overall mortality by 23%. The effect of vitamin A supplementation in newborns on morbidity and mortality is less clear, with three studies in India, Indonesia and Nepal showing reductions in neonatal mortality of 22%, 64% and 15% respectively, but with 2 other trials in Africa reporting no effect. In view of the expected health benefits of improved vitamin A status of infants, WHO currently recommends that women should receive a high dose (200.000 IU ) of vitamin A within the first 6 weeks postpartum, in order to improve maternal vitamin A status, the vitamin A content of breast milk, and thereby the vitamin A status of their infants. However, several recent trials in which women received 200.000 IU vitamin A directly post-partum, reported no improvement in vitamin A status of either mother or her infant at 6 mo of age, not even after doubling the dose to 400.000 IU. In these studies vitamin A was given within a week of delivery, the current typical practice even though WHO actually states a window of 6 weeks after delivery. In contrast, 2 earlier studies in Bangladesh and Indonesia reported a large impact of post-partum maternal supplementation on vitamin A status in infants at 6 mo of age. In these studies, women received a high dose vitamin A supplement not directly post-partum, but somewhere in the first 6 weeks after delivery. The WHO recommendation on maternal post-partum vitamin A supplementation was based on the effects observed in these earlier studies, but the more recent studies suggest now that this intervention is not effective, and that millions of women are receiving a high dose vitamin A supplement without clear benefits for vitamin A status of either the women or their children. The difference in timing between the earlier studies and the recent studies of giving the vitamin A may hold the key, and we believe we have identified the biological reason why timing of the supplementation could be of the utmost importance: the inflammatory response to delivery.
Delivery induces a considerable physiological inflammatory response, with a distinct acute phase response, of the same magnitude as seen for instance in pulmonary tuberculosis patients. We believe that the lack of effect of the current practice of giving a high dose vitamin A supplement directly post-partum is due to the acute phase response induced by the delivery, and that the intervention would be successful if the supplementation was given after the acute phase response has faded away after 3 - 6 weeks. There is currently no data available on the vitamin A bioavailability in lactating women, but a study in Zambian pre-school children investigated the effectiveness of a high dose vitamin A supplementation campaign in children, and showed that this was only successful in children without inflammation. Children who had signs of inflammation had no increase in vitamin A status. Inflammation and the accompanying acute phase response are also known to affect the availability of other micronutrients besides vitamin A, such as iron and zinc.
Objective(s) and Hypothesis(es):
Hypothesis The acute phase response (APR) induced by delivery reduces vitamin A bioavailability, and interferes with current maternal post-partum high dose vitamin A supplementation programs worldwide.
Objective 1 To determine the effects of the acute phase response on vitamin A bioavailability.
Objective 2 To determine the time course of the acute phase response after delivery.
Overall goal To improve the effectiveness of the current WHO recommendation of post-partum maternal high dose vitamin A supplementation by determining the optimal timing for supplementation in relation to the post-partum APR.
Design and Methods:
A randomised, placebo-controlled, double-blind trial in 400 women, comparing the effects of the recommended dose of 200.000 IU of vitamin A given within the first week post-partum (current practice, 200 women) with the effect when given at 6 weeks post-partum, which is still within the WHO recommended intervention window (200 women). Main outcomes will be maternal and infant vitamin A status 6 months post-partum, breast milk vitamin A concentrations and the time-course of acute phase response, to establish the optimal time after delivery for vitamin A supplementation. Secondary outcomes will be morbidity of the infants during the first 6 months of life and anthropometrical indices of the infants at 6 mo of age.
Potential Impact:
If our hypothesis is true, the current global health strategy of postpartum vitamin A supplementation to improve vitamin A status of mothers and infants can be made effective just by changing the timing. This will have significant implications for global health policies, with important consequences for infant survival worldwide by improving vitamin A status and reducing morbidity and mortality from infectious diseases during the first 6 months of life. Moreover, results of the study will have important consequences for other micronutrient health programs, such as vitamin A supplementation for children above 6 months of age and iron or zinc supplementation programs, as these are also affected by the acute phase response. Overall, the results of this research will contribute to improving child survival worldwide.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vitamin A directly post-partum | Active comparator | Dietary Supplement: vitamin A200.000 IU of vitamin A within 3 days of delivery |
| vitamin A delayed | Experimental | Dietary Supplement: vitamin A200.000 IU vitamin A 6 weeks post-partum |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy women giving birth to a singleton infant.
Key exclusion criteria (4 listed)
- Women giving birth to infants weighing < 1500 gram (very low birth weight infant) will be excluded.
- Also excluded will be twin pregnancy, because of different growth patterns of the infants and congenital abnormalities interfering with normal growth.
- Furthermore, women indicating that they are planning not to breast feed their baby will be excluded, as well as women who experience delivery complications which result in prolonged (> 3 days) hospital stay.
- Complications such as eclampsia or excessive blood loss will be registered, but will not be a reason for exclusion per se.
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 Ahigh dose vitamin A, 200.000 IU | Dietary supplement | vitamin A delayed, vitamin A directly post-partum |
Primary outcome
vitamin A status of lactating women 6 mo post-partum vitamin A status of infants 6 mo of age acute phase proteins concentrations (CRP, AGP) at several time-points during the first 6 mo post-partum
Time frame: several times points during the first 6 mo post-partum (different time points for different indicators)
plasma retinol 6 mo post-partum (women and infants), breast milk retinol (6 weeks, 4 mo and 6 mo post-partum), liver retinol stores of infants 6 mo post-partum acute phase proteins, at 2 weeks, 6 weeks, 4 mo and 6 mo post-partum (women)
Time frame: 2 and 6 weeks, 4 mo and 6 mo post-partum
1 secondary outcome
morbidity infants during the first 6 mo of life anthropometry at 6 mo post-partum
Time frame: 6 mo of age
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 11 Oct 2012.
- Background: PubMed 19175946Friis H, Range N, Braendgaard Kristensen C, Kaestel P, Changalucha J, Malenganisho W, Krarup H, Magnussen P, Bengaard Andersen A. Acute- phase response and iron status markers among pulmonary tuberculosis patients: a cross-sectional study in Mwanza, Tanzania. Br J Nutr. 2009 Jul;102(2):310-7. doi: 10.1017/S0007114508162122. Epub 2009 Jan 28.
- Background: PubMed 17391562Ayah RA, Mwaniki DL, Magnussen P, Tedstone AE, Marshall T, Alusala D, Luoba A, Kaestel P, Michaelsen KF, Friis H. The effects of maternal and infant vitamin A supplementation on vitamin A status: a randomised trial in Kenya. Br J Nutr. 2007 Aug;98(2):422-30. doi: 10.1017/S0007114507705019. Epub 2007 Mar 29.
- Background: PubMed 18502294Wieringa FT, Dijkhuizen MA, van der Meer JW. Maternal micronutrient supplementation and child survival. Lancet. 2008 May 24;371(9626):1751-2. doi: 10.1016/S0140-6736(08)60758-8. No abstract available.
- Background: PubMed 15531679Dijkhuizen MA, Wieringa FT, West CE, Muhilal. Zinc plus beta-carotene supplementation of pregnant women is superior to beta-carotene supplementation alone in improving vitamin A status in both mothers and infants. Am J Clin Nutr. 2004 Nov;80(5):1299-307. doi: 10.1093/ajcn/80.5.1299.
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.
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 in people with Healthy Women Giving Birth to Singleton Infants, run by Institut de Recherche pour le Developpement at 1 site in Vietnam.
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 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 11 Oct 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 Vietnam. 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 of lactating women 6 mo post-partum vitamin A status of infants 6 mo of age acute phase proteins concentrations (CRP, AGP) at several time-points during the first 6 mo post-partum (time frame: several times points during the first 6 mo post-partum (different time points for different indicators)). 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 NCT00952640, which also lists 4 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 11 Oct 2012.