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

University of the Punjab

Status and phase: Completed; Phase 2

Conditions: Malnutrition in Children

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

Study type: Interventional

Funder types: Other

Identifiers

NCT03170479

UPunjab

Details and patient eligibility

About

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.

Full description

1. 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.
2. Research Settings: The study will be conducted in Dera Ghazi Khan division at, Basic Health Units (BHU).
3. Study design: Randomized Controlled Trial.
4. 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.

Enrollment: 185 patients

Sex: All

Ages: 6 to 59 months old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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185 participants in 2 patient groups, including a placebo group

RUTF with Vitamin D

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)

Dietary Supplement: Vitamin D

RUTF with Placebo

Placebo Comparator group

Description:

Placebo arm will receive Ready to Use Therapeutic Food (RUTF) and extra virgin olive oil as Placebo.

Treatment:

Dietary Supplement: Ready to Use Therapeutic Food (RUTF)