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Aquasol A (Vitamin A Palmitate) - Summary

 
 



AQUASOL A SUMMARY

AQUASOL A® Parenteral

AQUASOL A ® Parenteral (water-miscible vitamin A Palmitate) provides 50,000 USP Units of vitamin A per mL as retinol (C20H30O) in the form of vitamin A palmitate, a light yellow to amber oil.

Vitamin A injection is effective for the treatment of vitamin A deficiency.

The parenteral administration is indicated when the oral administration is not feasible as in anorexia, nausea, vomiting, pre- and postoperative conditions, or it is not available as in the “Malabsorption Syndrome” with accompanying steatorrhea.

Pediatric Use

Vitamin A treatment for deficiency states has been recognized as an especially effective and important therapy in the pediatric population.

Vitamin A supplementation for deficiency states in this population has been addressed by the Committee on Clinical Practice Issues of the American Society for Clinical Nutrition, by the American Society for Parenteral and Enteral Nutrition, and by the World Health Organization.


See all Aquasol A indications & dosage >>

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.

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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.

more trials >>


Page last updated: 2013-02-10

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