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Children (Exclusively breast fed: 6mo - 3yrs, and who are not exclusively breast fed 3mo to 3 yrs) with infantile cholestasis syndrome will be randomized to either recieve indigenously prepared oral nutritional supplement (energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician (Group A). The control group (Group B) in comparison will receive standard nutritional counseling from a trained dietician but will not receive any additional nutritional supplement. All the children will be followed up at 1 month, 3 months, 6 months, 9 months and 1 year after inclusion. Clinical, nutritional assessment and laboratory data will be collected at each visit. Additionally IL-6 levels will be done at each visit in children of both arms of the intervention group.
The outcomes of interest will be growth and improvement of nutritional status parameters, hepatic morbidity (ascites, gastrointestinal bleeding, encephalopathy, {SBP (Spontaneous Bacterial Peritonitis), HRS (Hepatorenal Syndrome), etc and outcome (improvement, death or Liver Transplantation}.
All children will receive individualized standard treatment for infantile cholestasis syndrome including vitamin supplements/endotherapy/ beta blockers/ prophylaxis for SBP (Spontaneous Bacterial Peritonitis)/cholangitis (to at risk children) and drug therapy wherever indicated (steroids/ copper chelation/ UDCA).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutritional Supplement | Experimental | Diet Counseling (Energy=200 kcal/kg/day, (present weight) protein =3-4 gm/kg/day) Nutritional supplement (Providing extra 40 kcal/kg/day) |
|
| Standard nutritional treatment | Active Comparator | Diet counselling only (Energy=200 kcal/kg/day (present weight) protein =3-4 gm/kg/day). Standard nutritional treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutritional Supplement | Dietary Supplement | Energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age. |
| Measure | Description | Time Frame |
|---|---|---|
| To study the effect of special fortified indigenous diet on growth,and outcome in children with infantile cholestasis syndrome | Growth is a composite outcome defines as age and sex appropriate anthropometric measures- weight , height, mid arm circumference, triceps skin fold thickness, subscapular skin fold thickness. | 1 year |
| To study the effect of special fortified indigenous diet on hepatic morbidity in children with infantile cholestasis syndrome | hepatic morbidity is a composite outcome comprising of ascites, hepatic encephalopathy, spontaneous bacterial peritonitis, intercurrent infections, variceal bleed. | 1 year |
| To study the effect of special fortified indigenous diet on outcome in children with infantile cholestasis syndrome | Outcome is defined as survival with native liver, death or liver transplantation | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| To study the levels of IL-6 before & after nutritional therapy in malnourished children with Chronic Liver Disease | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Seema Alam, MD | Institute of Liver and Biliary Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of liver and Biliary Sciences | New Delhi | National Capital Territory of Delhi | 110070 | India |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Standard Nutritional Treatment | Dietary Supplement | Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age |
|