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

NCT00388921 | Completed

• 1 other identifier: 2005-033
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Infections; Diarrhea; Malnutrition

Keywords

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.

Outcome Measures

Primary Outcomes (2)

• Resolution of diarrhoea

• Resolution of ALRI

Secondary Outcomes (6)

• 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

Interventions

Vitamin A DRUG

Eligibility Criteria

• Age: 6 Months - 59 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Failure to obtain consent
• Received a dose of vitamin A within the last three months
• History of night blindness or eye signs of vitamin A deficiency
• Measles or history of measles within last 8 weeks \[56\]
• 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
• Trisomy-21
• Cerebral palsy
• Any other known chronic disease (e.g. hepatic, renal or congenital disorder) or malignant condition.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

Dhaka Hospital, ICDDR,B

Dhaka, 1212, Bangladesh

Location

Related Publications (1)

• Sattar S, Ahmed T, Rasul CH, Saha D, Salam MA, Hossain MI. Efficacy of a high-dose in addition to daily low-dose vitamin A in children suffering from severe acute malnutrition with other illnesses. PLoS One. 2012;7(3):e33112. doi: 10.1371/journal.pone.0033112. Epub 2012 Mar 27.

  PMID: 22479361 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections; Diarrhea; Malnutrition; Body Weight; Cough; Common Cold

Interventions

Vitamin A

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Picornaviridae Infections; RNA Virus Infections; Virus Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Diterpenes; Pigments, Biological; Biological Factors

Study Officials

• Samima Sattart, MBBS

  International Centre for Diarrhoeal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2006
• First Posted: October 17, 2006
• Study Start: October 1, 2005
• Primary Completion: December 31, 2007
• Study Completion: December 31, 2007
• Last Updated: February 11, 2022

Record last verified: 2005-11

Locations

BA (1)