A study to compare the efficacy of daily 4000 IU versus 6000 IU of oral vitamin D3 in the treatment of vitamin D deficient over weight and obese children.

Comparative efficacy of daily 4000 IU versus 6000 IU of oral vitamin D3 in the treatment of vitamin D deficient overweight and obese children - A Randomized controlled trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2021/02/031591

Enrollment

Registered

2021-02-26

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E660- Obesity due to excess calories

Interventions

Intervention1: Oral Vitamin D3 4000 IU: Over weight and obese children with vitamin D levels 20ng.mL are given Oral Vitamin D3 supplement 4000 IU along with Tablet Calcium 5000 mg/day Intervention2:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Overweight and obese defined as per Indian Academy of Pediatrics (IAP) 2.Vitamin D levels <20 ng/mL, as per global consensus recommendations, 2016

Exclusion criteria

Exclusion criteria: 1. Pathological obesity (syndromic, monogenic, endocrine, drug induced) 2. Already taking vitamin D or calcium supplements in the last 3 months 3. Children with underlying co-morbidity including Chronic Liver Disease (CLD), Chronic Kidney Disease (CKD), type 1 Diabetes mellitus, thyroid dysfunction or any disorder that affects bone or mineral metabolism 4. Children who are taking anti-convulsants, anti-tubercular or steroid therapy 5. Children who have undergone surgery or are immobilized for more than 1 year

Design outcomes

Primary

Measure	Time frame
1. Efficacy of two treatment regimens will be assessed comparing the proportion of subjects in both the groups with: â?¢ Normalisation of serum 25(OH) D (20-100 ng/mL) Timepoint: three months	—

Secondary

Measure	Time frame
1. Safety of therapy will be estimated by measuring prevalence of the following in the 2 groups of subjects at 1 and 3 months â?¢ Hypercalcemia (11mg/dl) â?¢ Hypercalciuria (urinary calcium to creatinine ratio 0.2 mg/gm of creatinine) â?¢ Hypervitaminosis D (serum 25(OH) D 100 ng/ml) 2. Correlation of levels of vitamin D with HbA1c and lipid profile parameters- total cholesterol, serum triglycerides, HDL and LDL levels in both the groups. Timepoint: Three months	—

Measure

Time frame

1. Safety of therapy will be estimated by measuring prevalence of the following in the 2 groups of subjects at 1 and 3 months â?¢ Hypercalcemia (11mg/dl) â?¢ Hypercalciuria (urinary calcium to creatinine ratio 0.2 mg/gm of creatinine) â?¢ Hypervitaminosis D (serum 25(OH) D 100 ng/ml) 2. Correlation of levels of vitamin D with HbA1c and lipid profile parameters- total cholesterol, serum triglycerides, HDL and LDL levels in both the groups. Timepoint: Three months

—

Countries

India

Contacts

Public ContactDr Preeti Singh

Kalawati Saran Childrens Hospital

drpreetisingh3@gmail.com9810552515

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 5, 2026