NEWS HIGHLIGHTS
Published Studies Related to Aquasol A (Vitamin A Palmitate)
Effect of vitamin A adjunct therapy for cerebral malaria in children admitted to
Mulago hospital: a randomized controlled trial. [2012]
CONCLUSIONS: Vitamin A as adjunct therapy did not significantly reduce coma
Olfactory function in patients with postinfectious and posttraumatic smell
disorders before and after treatment with vitamin A: a double-blind,
placebo-controlled, randomized clinical trial. [2012]
STUDY DESIGN: Double-blind, randomized, placebo-controlled clinical trial... CONCLUSIONS: The systemic application of vitamin A at a dose of 10,000 IU per day
Efficacy of a high-dose in addition to daily low-dose vitamin A in children
suffering from severe acute malnutrition with other illnesses. [2012]
and/or acute lower respiratory tract infection (ALRI)... CONCLUSIONS: Efficacy of daily low-dose VA compared to an additional single
Multivitamin therapy for recurrent aphthous stomatitis: a randomized,
double-masked, placebo-controlled trial. [2012]
have been implicated as a possible cause... CONCLUSION: Daily multivitamin supplementation, with the RDI of essential
Maternal vitamin A and beta-carotene supplementation and risk of bacterial vaginosis: a randomized controlled trial in rural Bangladesh. [2011.12]
BACKGROUND: Bacterial vaginosis (BV) in pregnancy is linked to preterm birth, but its risk factors are not well understood. Micronutrient deficiencies may be associated with an increased risk of this condition. OBJECTIVE: We assessed the effect of weekly vitamin A or beta-carotene supplementation during pregnancy until 3 mo postpartum on BV risk in rural northeastern Bangladesh... CONCLUSIONS: Weekly vitamin A supplementation reduced the risk of maternal BV in this rural Bangladeshi population. Enhancement of vitamin A status before and during pregnancy may reduce the risk of BV in areas with vitamin A deficiency. This trial is registered at clinicaltrials.gov as NCT00198822.
Clinical Trials Related to Aquasol A (Vitamin A Palmitate)
Vitamin A and Maternal-Infant Flu Vaccine Response [Not yet recruiting]
Influenza viral infection can cause serious illness among young infants 0-6 months of age.
However, inactivated influenza vaccine is not recommended for this age group but pregnant
women can be vaccinated during 2nd - 3rd trimester to induce passive immunization of their
infants. Nevertheless vitamin A deficiency is highly prevalent among pregnant women in
Bangladesh, >50% pregnant women consume less vitamin A than the recommended level. Given the
fact that both clinical and sub-clinical vitamin A deficiency impair vaccine specific
immunity, in this proposed study, we aim to investigate whether maternal vitamin A
supplementation improve influenza vaccine specific immune responses among pregnant women and
the passive protection of their infants.
In a placebo controlled clinical trial, sixty six mothers will be randomly assigned to
receive either 10,000 IU vitamin A or placebo capsules weekly from second trimester to 6
month postnatal period. At 26-28 weeks of gestation, all mothers will be vaccinated with
inactivated, trivalent influenza virus vaccine. Maternal and cord blood will be collected
for vitamin A and influenza virus specific IgG assessment. Colostrum and breast milk at
6-month will be collected for vitamin A and influenza virus specific secretory IgA
assessment. Venous blood (2-3 ml) will be obtained from all infants at the age of 6 months
for vitamin A and influenza virus specific IgG assessment as well as infants' nasal swab for
influenza virus specific secretory IgA.
Intratracheal Vitamin A Administration With Surfactant for Newborn Respiratory Distress Syndrome [Not yet recruiting]
To research the effect of vitamin A to newborn respiratory distress syndrome by
intratracheal administration with surfactant.
Making Maternal Post-partum Vitamin A Supplementation Effective: The Role of Timing and Inflammation [Recruiting]
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
Effect of Vitamin A Supplementation on Immune Responses in Human Neonates [Not yet recruiting]
Vitamin A supplementation (VAS) significantly reduces all-cause mortality when given after 6
months of age, but has a null or detrimental effect when given between 1-5 months. Studies
of neonatal VAS (NNVAS) have produced conflicting findings. These age-pattern variations
might result from immunological interactions between VAS and vaccines. The potential
efficacy of NNVAS is being retested in 3 large new intervention trials with mortality as
endpoint. Complementary mechanistic studies in animals and in human infants in The Gambia
(this proposal) and Bangladesh have been commissioned to run in parallel.
The investigators will use a 2-arm double blind RCT to test whether NNVAS modulates the
early ontogeny of human immune development. Neonates, recruited through a peri-urban clinic
in The Gambia, will receive either 50,000 International Units (IU) VAS orally within 48
hours of birth (intervention group, n=100) or a placebo (control group, n=100). Male and
female neonates will be randomized separately at enrolment for later analyses by sex. All
infants will be followed up from birth to age 1 year. A broad panel of immunological
outcomes will examine whether NNVAS: a). normalises thymic development (thymic index by
ultrasound); b). skews mycobacterial and recall antigen responses towards a Th2 profile; c).
diminishes Th1 and Th17 reactivity to mycobacterial and recall antigens; d). diminishes the
tuberculin skin test (TST) response; e). causes increased innate immune reactivity; f).
increases the frequency of circulating regulatory T cells (Tregs) expressing gut homing
receptors; g). enhances B cell immune responses after routine vaccination (increase of B
cell numbers and activation status); h). increases circulating IgA in mucosal immune
compartment, especially oral polio vaccine (OPV) specific IgA post-vaccination; i).
decreases bacterial translocation, by improving mucosal barrier function; and j). decreases
markers of infection or inflammation. Growth and morbidity will also be assessed.
Efficacy of Newborn Vitamin A Supplementation Versus Placebo in Improving Child Survival (NeoVitA Trial) [Recruiting]
The study will be a large randomized controlled trial to assess the efficacy and safety of
neonatal vitamin A supplementation administered to neonates once orally either on the day of
birth or in the next 2 days in improving infant survival in the first 6 months of life.
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