To compare the efficacy of water soluble vitamin D3 versus fatsoluble vitamin D3 in vitamin D deficient adults and elderly.

Completed

Conditions: Vitamin D deficient adults

Registration Number: CTRI/2017/10/010187

Lead Sponsor: International Life Sciences Institute India

Brief Summary: In this randomized prospective study, we aim to evaluate the efficacy of micellized vitamin D over non-micellized Vitamin D in adults and elderly. Two hundred healthy adults (100 males and 100 females) and 200 healthy (100 males and 100 females) elderly individuals females), with vitamin D deficiency ( serum 25 (OH) D < 20 ng/mL) will be included in this study. A thorough history will be taken followed by a detailed clinical and systemic examination. Vitamin D3 supplementation will be given 60000 IU every month in a randomized manner with either micellized or non-micellized of vitamin D3 for a period of 12 months . Blood samples will be collected at baseline and after 6 & 12 months of supplementation. The samples will be analyzed for serum 25(OH) D, parathyroid hormone (PTH), calcium, phosphates, alkaline phosphatase, bone markers (serum PINP & CTX) and inflammatory markers (IL-1, 2, 6 and 10, IFN- Î³, ultrasensitive CRP & TNF-Î±). Urine samples collected at baseline and after 6 & 12 months of supplementation with oral cholecalciferol, were analyzed for calcium creatinine ratio.

**Results:**

Eighty-nine subjects in group A and 77 in group B completed the trial. Subjects in both groups had significant increase in their serum 25(OH)D levels following supplementation (Group A: 8.6 Â± 4.4 ng/mL to 30.7 Â± 7.5 ng/mL (p < 0.001); Group B: 9.1 Â± 4.1 to 23.1 Â± 6.4 ng/mL (p < 0.001). Participants in micellized group had an additional increase of 8.1 ng/mL in serum 25(OH)D levels (p<0.001). Eighty one (91%) subjects in group A and fifty two (67%) in group B achieved serum 25(OH)D >20ng/ml (p <0.0001) following supplementation. No hypercalcemia or hypercalciurea was noted during the trial.

**Conclusion**:

Supplementation with both micellized and non-micellized vitamin D3 result in a significant rise in serum 25(OH)D levels. Micellized vitamin D3 appears to be more efficacious.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 200

Inclusion Criteria

Adults and elderly with vitamin D deficiency.

Exclusion Criteria

Subjects suffering from any systemic disorders affecting the bone mineral health.
Adults and elderly consuming calcium, vitamin D or other medications like ATT, anticonvulsants etc, which are likely to impact bone mineral metabolism.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the efficacy of micellized vitamin D3 versus	After 6 and 12 months of supplementation
fat soluble vitamin D3 in adults and elderly with known	After 6 and 12 months of supplementation
vitamin D deficiency	After 6 and 12 months of supplementation

Secondary Outcome Measures

Name	Time	Method
Effect of vitamin D3 supplementation on bone markers	(PINP, NTX) and inflammatory markers (ultrasensitive

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Dr G Sethuraman
Principal investigator
01126594369
aiimsgsr@gmail.com