Health Condition 1: E660- Obesity due to excess calories Health Condition 2: E669- Obesity, unspecified Health Condition 3: E668- Other obesity Health Condition 4: E663- Overweight
Conditions
Interventions
Intervention1: Group A: Consenting children fulfilling inclusion and exclusion criteria shall be randomised into two groups, Group A and B. At recruitment baseline level of serum 25(OH) vitamin D, ser
Sponsors
AIIMS Rajkot
Eligibility
Inclusion criteria
Inclusion criteria: (1) Children aged 5 to 16 years, identified as overweight or obese based on Indian Academy of Pediatrics (IAP) 2015 percentile BMI charts. Overweight- BMI between 85th -95th centile based on Indian Academy of Pediatrics (IAP) 2015 BMI charts for same age & sex. Obese- BMI at or above 95th centile based on Indian Academy of Pediatrics (IAP) 2015 BMI charts for same age & sex.
Exclusion criteria
Exclusion criteria: (1) Children with a history of vitamin D supplementation (greater than recommended daily allowance) in the last 6 months. (2) Children receiving drugs that could interfere with vitamin D metabolism e.g. antiepileptics. (3) Children with 25(OH)D levels more than or equal to 20 ng/mL and levels less than 12 ng/mL. (4) Children with malabsorption syndromes that could impair the oral absorption of vitamin D. (5) Children with rickets or signs and symptoms of vitamin D deficiency.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To evaluate the difference in rise of serum 25(OH)D level in both groups at the end of six months. 2. To compare the proportion of children maintaining normal level of serum 25(OH)D level (more than 20ng per ml) after vitamin D3 supplementation at the end of 6 months between the two groups.Timepoint: Baseline at recruitment and at follow up after 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate and compare the effect of body composition variables (total body fat and visceral body fat) on change in serum vitamin D levels in both groups.Timepoint: Baseline at recruitment and at follow up after 6 months;To compare the cost effectiveness of both regimesTimepoint: Baseline at recruitment and at follow up after 6 months;To correlate heart rate variability (HRV) with vitamin D supplementation in both groups.Timepoint: Baseline at recruitment and at follow up after 6 months | — |
Countries
India
Contacts
Public ContactDr Pinky Meena
All India Institute Of Medical Sciences (AIIMS), Rajkot
Outcome results
None listed