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| Sponsored by: |
International Centre for Diarrhoeal Disease Research, Bangladesh |
|---|---|
| Information provided by: | International Centre for Diarrhoeal Disease Research, Bangladesh |
| ClinicalTrials.gov Identifier: | NCT00388921 |
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: | Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety Study |
| 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 |
Inclusion Criteria:
Severe malnutrition as defined by the presence of any of the followings:
Exclusion Criteria:
Contacts and Locations| Bangladesh | |
| Dhaka Hospital, ICDDR,B | |
| Dhaka, Bangladesh, 1212 | |
| Principal Investigator: | Samima Sattart, MBBS | International Centre for Diarrhoeal Disease Research, Bangladesh |
More Information
| Study ID Numbers: | 2005033 |
| Study First Received: | October 15, 2006 |
| Last Updated: | October 16, 2006 |
| ClinicalTrials.gov Identifier: | NCT00388921 History of Changes |
| Health Authority: | Bangladesh: Ethical Review Committee |
|
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. |
|
Retinol Diarrhea Signs and Symptoms, Digestive Cough Edema Trace Elements Body Weight Signs and Symptoms Malnutrition |
Retinol palmitate Respiratory Tract Infections Respiratory Tract Diseases Vitamins Vitamin A Nutrition Disorders Micronutrients Dehydration |
|
Diarrhea Signs and Symptoms, Digestive Growth Substances Physiological Effects of Drugs Infection Pharmacologic Actions Signs and Symptoms |
Malnutrition Respiratory Tract Infections Respiratory Tract Diseases Vitamin A Vitamins Nutrition Disorders Micronutrients |