Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00374023
Status:
COMPLETED
Last Update Posted:
2017-11-28
First Post:
2006-09-07
Brief Title:
A Study on Immunological Effect of Vitamin A and Zinc in a Placebo Controlled 4 Cell Trial
Sponsor:
International Centre for Diarrhoeal Disease Research Bangladesh
Organization:
International Centre for Diarrhoeal Disease Research Bangladesh
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1993-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Vitamin A deficiency in children is associated with increased mortality and morbidity due to respiratory tract and diarrhoeal infections Vitamin A supplementation has been shown in some studies to reduce morbidity due to respiratory diseases However other studies to reduce could not document such benefit from vitamin A supplementation The role of vitamin A on immunity in humans is not yet clear due to inconclusive results To evaluate immune changes and compare those with of a known immunopotent agent like zinc a randomised double blind study will be carried out in 1-3 year aged children without acute illness and wtage between 61 and 70 of NCHS standard Baseline anthropometry and vitamin A status will be determined using MRDR test and immune status will be estimated Each group consisting of 50 children will either receive vitamin A 200000 IU over 7 days or 40 m elemental zinc daily for 7 days or both or placebo After 8 weeks immunity test will be repeated Immunity tests will include serum 1gA 1gM 1gG an lymphocyte simulation and 8 antigen multiple skin test Undiminished children will be given measles vaccine and serum titre will be measured before and after supplementation Vitamin A status will be estimated by MRDR test Vitamin A2 will be given and 1ml blood sample will be collected after 5 hours to see the ratio of vitamin A1 and A2 006 as cut off as the modified relative dose response MRDR test Doses of vitamin A or zinc will be repeated at the completion of 2 month The results will be compared between groups and within groups at baseline and after 6 weeks The study will generate information which will help to examine the immune response of vitamin A therapy in children as an underlying factor for reduction in mortality or morbidity The study will be completed within a year
Detailed Description:
Immunological indicators will be monitored at the beginning and after 8 weeks of giving vitamin A or zinc in a double blind randomized trial A clinical based study will be done to see the effect of zinc or vitamin A supplementation in malnourished subjects Vitamin A status will be estimated using the newer indicator modified relatively dose response MRDRProcedureStudy populationChildren aged 1 to 3 years will be included Forty children in each group will be assigned to either group A group B and group C and group D children will be selected from families within Dhaka city who come to the diarrhoea treatment centre of ICDDRBInclusion criteria1 Children aged between 1 and 3 years having weight for age between 70 and 61 of NCHS standard2 Who come to the out patient department of ICDDRB for treatment of acute water diarrhoea with3 No signs of vitamin A deficiency non invasive diarrhoea and without systematic infection and has not received vitamin A during last 4 months4 Who has not received measles vaccine and did not have measles primarily identified for the study5 Children who has not reside in and around Dhaka city After one week recovery from diarrhoea1 Baseline immunological profile will be studied2 Intervention for one week at the schedule doses and immunological profile will be repeated after 8 weeksStudy groups areA Zinc B Vitamin A C Zinc and vitamin A D PlaceboExclusion criteria1 Children who needs immediate vitamin A supplementation clear sign of vitamin deficiency2 Children who received vitamin A within the last 4 months3 Children with other systematic infection4 Subjects who develop any kind of sign and symptoms of vitamin A deficiency will be given vitamin A and will be analysed separatelyRandomisation procedure Parents who give their consent for the study will be selected Children will be randomised into four groups to receive either of the treatments A master randomisation chart will be prepared using table in permuted block design by dividing serial number into four equal groups There will be no need for stratification but according to the selection criteria better nourished 70 wtage or severely malnourished 60 children will be excluded Severely malnourished patients with diarrhoea may immediately need vitamin A or well nourished will not show effect of supplements Steps will be kept to compensate dropoutsThe intervention and non-intervention groups will receive identical bottles and syrups with some flavour and only single unique serial number will be written outside the bottles The number will indicate an exact subject of study and will be kept out of the reach of the investigators The children will receive the 2nd dose at 8 weeks with vitamin A or zinc who has not received that in the first dose without breaking the randomization code The code will be broken only after completion of study and analysis according to groupsBase line survey will be done to take socio-economic information dietary habits previous illness immunization washing of hands and water use frequency of cooking of food containing vit A cooking method and frequency of use of green leafy vegetablesIn the beginning of the study baseline vitamin A status will be determined using MRDR test Anthropometry will be done to select children at the baseline at the end of 8 weeks and subsequent months for 6 months Duration frequency doseOne teaspoonful 5 ml syrup will be given in a twice-daily schedule for 7 daysComposition of syrupFor all groups the main vehicle and bulk of the base syrup will consist of the same chemicals in addition to this each group will have either of the treatment substance ie zinc or vitamin A or both or noneSyrup A Quantity per 5 ml Zinc acetate 20 mg elemental
Syrup B
Vitamin A palmitate 15000IU
Syrup C
Zinc 20 mg elemental vitamin A 15000 IU Syrup D Y base substance Base substance Ascorbic acid 30 mg Glycerine USP 12 ml Propylene glycol USP 075 ml Sorbitol 70 BP 20 ml Methyl Paraban USFN 35 mg Polysorbate-80 50 mg Tween-80 BPC Lemon oil pH grade 00125 ml Caramel Brown colour 1 mg Powder water 075 ml Organization of the studyThe study will be conducted among the children who will attend the out patient department of the clinical research centre of ICDDRB Children will be selected at the acute diarrhoea phase who will attend only with non invasive simple or mild diarrhoea within the nutritional status defined earlier of NCHS standard The children will be taken for study 1 week after the recovery of diarrhoea and the first immunological test at base line will be done at this time Mothers will be instructed on the dose A twice-daily dose of syrup for one week will be schedule for better compliance of the children After completion of doses at 8 weeks the immunity test will be repeated a 8 weeks Tears will be collected in a small piece of sponge and will be used for secretary 1 gA estimation Skin test for Cell Medicated Immunity will be performed in each child regardless of treatment group with multitest kit developed by Institute Merieux These children will be followed up every alternate day for the 1st week and then weekly for development of any illness for 2 months Necessary treatment measures will be undertakenClinical care Patient care will be provided on clinical problems identified during treatment of diarrhoea or follow up A team of medical officers and paramedics will examine and record the vitamin A deficiency symptoms and other medical problems on a predesigned questionnaire and provide the necessary care Any children develop an acute symptom of night blindness or Bitots spot will be given a vitamin A capsule 200000 in which will be recordedBaseline test on immunity will be performed by the following testsComponents of immunity and other variables1 Eight antigens multiple skin tests measured by 48 hours2 Eight 1gA 1gM3 MRDR plasma 1gA 1gM 1gGThis will require 2 ml blood4 Lymphocyte proliferation assaysFor T lymphocytes- PHA Con A antigen will be used For T and B lymphocytes - PWM Poke weed MitogenThis will require 3 ml blood in heparinized tube 5 Lymphocyte Phenotype using monoclonal antibodies to CD3 CD4 CD8 CD20Schedules for immunity test skin test before dose and after 8 weeks MRDR will be done at base line and at 8 weeks6 Base line titre of measles antibody 1gG will be measured and will be followed by a dose of measles vaccine and titre be measure at 8 weeks of supplementation7 Serum zinc RBP albumin alkaline phosphatase at baseline after 8 weekAnthropometry will be done with weight height MUAC at base line at 8 weeksBody weight- will be measured nude with an electronic scale with a 1gLength- will be measured in knee-heel vernier with 1mm sensitivity Data collection on morbidityA predesigned questionnaire will be used to record incidence and duration of illness during the follow up period
Syrup B
Vitamin A palmitate 15000IU
Syrup C
Zinc 20 mg elemental vitamin A 15000 IU Syrup D Y base substance Base substance Ascorbic acid 30 mg Glycerine USP 12 ml Propylene glycol USP 075 ml Sorbitol 70 BP 20 ml Methyl Paraban USFN 35 mg Polysorbate-80 50 mg Tween-80 BPC Lemon oil pH grade 00125 ml Caramel Brown colour 1 mg Powder water 075 ml Organization of the studyThe study will be conducted among the children who will attend the out patient department of the clinical research centre of ICDDRB Children will be selected at the acute diarrhoea phase who will attend only with non invasive simple or mild diarrhoea within the nutritional status defined earlier of NCHS standard The children will be taken for study 1 week after the recovery of diarrhoea and the first immunological test at base line will be done at this time Mothers will be instructed on the dose A twice-daily dose of syrup for one week will be schedule for better compliance of the children After completion of doses at 8 weeks the immunity test will be repeated a 8 weeks Tears will be collected in a small piece of sponge and will be used for secretary 1 gA estimation Skin test for Cell Medicated Immunity will be performed in each child regardless of treatment group with multitest kit developed by Institute Merieux These children will be followed up every alternate day for the 1st week and then weekly for development of any illness for 2 months Necessary treatment measures will be undertakenClinical care Patient care will be provided on clinical problems identified during treatment of diarrhoea or follow up A team of medical officers and paramedics will examine and record the vitamin A deficiency symptoms and other medical problems on a predesigned questionnaire and provide the necessary care Any children develop an acute symptom of night blindness or Bitots spot will be given a vitamin A capsule 200000 in which will be recordedBaseline test on immunity will be performed by the following testsComponents of immunity and other variables1 Eight antigens multiple skin tests measured by 48 hours2 Eight 1gA 1gM3 MRDR plasma 1gA 1gM 1gGThis will require 2 ml blood4 Lymphocyte proliferation assaysFor T lymphocytes- PHA Con A antigen will be used For T and B lymphocytes - PWM Poke weed MitogenThis will require 3 ml blood in heparinized tube 5 Lymphocyte Phenotype using monoclonal antibodies to CD3 CD4 CD8 CD20Schedules for immunity test skin test before dose and after 8 weeks MRDR will be done at base line and at 8 weeks6 Base line titre of measles antibody 1gG will be measured and will be followed by a dose of measles vaccine and titre be measure at 8 weeks of supplementation7 Serum zinc RBP albumin alkaline phosphatase at baseline after 8 weekAnthropometry will be done with weight height MUAC at base line at 8 weeksBody weight- will be measured nude with an electronic scale with a 1gLength- will be measured in knee-heel vernier with 1mm sensitivity Data collection on morbidityA predesigned questionnaire will be used to record incidence and duration of illness during the follow up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None