Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan

Study Overview
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Brief Summary
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i. To examine the impact of malnutrition on development quotient of children ii. To determine the effectiveness of Ready to Use Therapeutic Food (RUTF) in improving the development quotient of severe acute malnourished children under five year of age. iii. To investigate the outcome of Vitamin D therapeutic doses intervention with RUTF rehabilitation on growth and development of malnourished children.

Detailed Description
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Research Instrument: For Development quotient Denver 2 screening form and tools will be used. Follow up of patients for three months and for recording of their weight Community management of acute malnutrition forms will be used. Denver screening tool will be used for child development quotient covering all areas of development, fine motor, gross motor, language and personal social contact. Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU). Study design: Randomized Controlled Trial. Data Collection: Lady Health Visitors (LHWs) will screen the children aged 6 months to 59 months in their community and will refer the severely malnourished children to Outpatient Therapeutic Programs (OTPs).Two groups of malnourished children will be made one study and one control group; one group will be treated with RUTF and extra virgin olive oil as placebo. Other will with RUTF and two mega doses of Vitamin D randomly, first after 15 days of enrollment and second after 15 days of first dose.

Official Title
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Developmental Screening and Nutritional Intervention of Severe Acute Malnourished Children in Southern Punjab, Pakistan

Conditions
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Malnutrition in Children

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Ready to Use Therapeutic Food (RUTF)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria All the selected children of Severe uncomplicated acute malnutrition of concerned age group whose parents or guardians have give written consent for the study Mid Upper Arm Circumference (MUAC) less than 11.5 cm or Weight For Height (WFH) less then minus 3 standard deviation. Exclusion Criteria Children above the concerned age group Refusal of parents for taking part in the study. Child having Severe Acute Malnutrition (SAM) with complications have loss of appetite, lower respiratory tract infection indicated by chest in drawing, severe vomiting. Temperature greater then 39°C or hypothermia less then 35°C, very pale, oedema, unconsciousness.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 59 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RUTF with Vitamin D<br>Two groups (arms) of malnourished children will be made, one study and one control group; Experimental arm will use RUTF and two mega doses of 200,000 IU vitamin D randomly first after 15 days of enrollment and second after 15 days of first dose. | Dietary Supplement: Vitamin D<br>* Two doses of Vitamin D supplementation in ampoules form (ED3) were procured. Ampoule contains Cholecalciferol in 200,000 IU both for oral and intra muscular use.<br>Dietary Supplement: Ready to Use Therapeutic Food (RUTF)<br>* RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.<br>|
| Placebo Comparator: RUTF with Placebo<br>Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo. | Dietary Supplement: Ready to Use Therapeutic Food (RUTF)<br>* RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight gain in children | More than 15% weight gain from enrollment date | 2 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Developmental Milestones of children | Normal or delayed development using Denver Developmental Screening Tool 2 (DDST2) | 2 Months |