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High/Low Dose Vit A in Diarrhea/ALRI in Severe PEM

This study has been completed.
Sponsor:
Information provided by:
International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier:
NCT00388921
First received: October 15, 2006
Last updated: October 16, 2006
Last verified: November 2005
  Purpose

Vitamin A deficiency is an important health problem globally including Bangladesh. The problem is greater among under-five children, particularly in malnourished. Vitamin A supplementation reduces morbidity from diarrhoeal diseases and also prevents future diarrhoea episodes. However, there are conflicting reports on the role of vitamin A supplementation on morbidity from acute lower respiratory infections (ALRI) including pneumonia. In non-malnourished children supplementation has been reported to be associated with increased incidence and morbidity of ALRI. The WHO committee[1] has reviewed both the risk and benefit of mega dose (200,000 IU) vitamin A supplementation during acute illness particularly diarrhoea, irrespective of the nutritional status of under-5 children and recommended vitamin A supplementation in areas where vitamin A status is low. In Bangladesh mega dose (200,000 IU) of vitamin A is routinely supplemented to under-5 children every 6 months. Absorption of vitamin A precursors from the GI tract is reduced in severely malnourished children, who are also lacking in retinol binding protein (RBP), required for transportation of retinol to target tissues. Thus it is established that a significant portion of the supplemented vitamin A is excreted in feces and urine of malnourished children. The excretion of vitamin A increases substantially during acute infections including diarrhoeal diseases. On the other hand, due to reduced RBP, concentration of free vitamin A increases in the body resulting in the possibility of adverse events including “pseudotumor cerebri”. It has recently been observed that low-dose daily supplementation of vitamin A to malnourished children produces a better effect on recovery from acute illness and also in preventing infectious diseases among under-five children. However, the limitations of those studies included a small sample size, delayed assessment of retinol after supplementation among the others. Thus WHO felt that the issue needs to be addressed in a well-designed clinical trial. We hope that our proposed study will enable us to compare the efficacy of low-dose daily administration of vitamin A with that of initial mega dose followed by daily low dose of vitamin A in malnourished children presenting with acute diarrhoeal diseases with or without ALRI. If the results of this study indicate that the daily low-dose has similar efficacy to that of the currently recommended mega dose followed by daily low-dose of vitamin A, would have important programmatic implications.


Condition Intervention
Respiratory Infections
Diarrhea
Malnutrition
Drug: Vitamin A

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by International Centre for Diarrhoeal Disease Research, Bangladesh:

Primary Outcome Measures:
  • Resolution of diarrhoea
  • Resolution of ALRI

Secondary Outcome Measures:
  • Duration of acute phase of illness
  • Time to nutritional rehabilitation (achieving of 80% of W/H)
  • Rates of weight gain
  • Morbidity developed during hospitalization such as nosocomial infections
  • Measurement of Serum retinol and RBP on admission, on day 3 and on day 15
  • Case fatality rates

Estimated Enrollment: 260
Study Start Date: October 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 6-59 months
  2. Either sex
  3. Severe malnutrition as defined by the presence of any of the followings:

    • Bipedal oedema
    • Weight (measured after correction of dehydration) for height Z score <-3 of the National Center for Health Statistics (NCHS) reference
    • Written informed consent of respective parents/ guardians for participation of the children in the study.
  4. Children having diarrhoea (watery or invasive) or cough and cold or both for the last 48 hours.

Exclusion Criteria:

  1. Failure to obtain consent
  2. Received a dose of vitamin A within the last three months
  3. History of night blindness or eye signs of vitamin A deficiency
  4. Measles or history of measles within last 8 weeks [56]
  5. Clinical suspicion of TB (evening rise of temperature, loss of appetite, gradual loss of weight, cough, night sweating) after applying modified Kenneth Jones criteria [57], shock other than due to hypovolaemia or hypoglycaemia, congestive cardiac failure, severe sepsis (hypothermia, tachycardia, tachypnea, hypotension) [58], and seizure disorders
  6. Trisomy-21
  7. Cerebral palsy
  8. Any other known chronic disease (e.g. hepatic, renal or congenital disorder) or malignant condition.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00388921

Locations
Bangladesh
Dhaka Hospital, ICDDR,B
Dhaka, Bangladesh, 1212
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
Investigators
Principal Investigator: Samima Sattart, MBBS International Centre for Diarrhoeal Disease Research, Bangladesh
  More Information

No publications provided by International Centre for Diarrhoeal Disease Research, Bangladesh

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00388921     History of Changes
Other Study ID Numbers: 2005033
Study First Received: October 15, 2006
Last Updated: October 16, 2006
Health Authority: Bangladesh: Ethical Review Committee

Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Vitamin A
Children
Severe malnutrition
Retinol
Retinol binding protein
Diarrhoea
ALRI
Age 6-59 months
Either sex
Severe malnutrition as defined by the presence of any of the followings:
Bipedal oedema
Weight (measured after correction of dehydration) for height Z score <-3 of the National Center for Health Statistics (NCHS) reference
Written informed consent of respective parents/ guardians for participation of the children in the study.
Children having diarrhoea (watery or invasive) or cough and cold or both for the last 48 hours.

Additional relevant MeSH terms:
Diarrhea
Malnutrition
Nutrition Disorders
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Digestive
Vitamin A
Vitamins
Growth Substances
Micronutrients
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014