Raman Kumar Marwaha1, A Mithal2, Neetu Bhari3, G Sethuraman3, Sushil Gupta4, Manoj Shukla4, Archana Narang5, Aditi Chadda5, Nandita Gupta6, V Sreenivas7, M A Ganie6. 1. International Life Sciences Institute, India. Correspondence to: Maj Gen Raman Kumar Marwaha, Scientific Advisor (Projects), International Life Science Institute (India). marwaha_ramank@hotmail.com. 2. Medanta Hospital Gurgaon, Haryana, India. 3. Department of Dermatology, AIIMS, New Delhi, India. 4. SGPGI, Lucknow, Uttar Pradesh, India. 5. Dr BR Sur Homeopathic Medical College, New Delhi, India. 6. Department of Endocrinology, AIIMS, New Delhi, India. 7. Department of Biostatistics, AIIMS, New Delhi, India.
Abstract
OBJECTIVE: To compare the adequacy and efficacy of different doses of vitamin D3 in pre-pubertal girls. DESIGN: Cluster Randomized controlled trial. SETTING:Public school in Delhi, India, between August 2015 and February 2016. PARTICIPANTS: 216 healthy pre-pubertal girls, aged 6.1-11.8 years. INTERVENTION: Daily supplementation with 600 IU (n=74), 1000 IU (n=67) or 2000 IU (n=75) of vitamin D3 under supervision for 6 months. OUTCOME MEASURES: Primary: Rise in serum 25 hydroxy Vitamin D (25(OH)D); Secondary: Change in bone formation and resorption markers. RESULTS: Following 6 months of supplementation, the mean (SD) rise in serum 25(OH)D was maximum with 2000 IU (24.09 (8.28) ng/mL), followed by with 1000 IU (17.96 (6.55) ng/mL) and 600 IU (15.48 (7.00) ng/mL). Serum 25(OH)D levels of ≥20 ng/mL were seen in 91% in 600 IU group , 97% in 1000 IU group and 100% in 2000 IU group. The overall mean (SD) rise in urinary calcium creatinine ratio (0.05 (0.28) to 0.13 (0.12) mg/mg), and serum procollagen type I N-terminal propeptide (538.9 (199.78) to 655.5 (218.24) ng/mL), and reduction in serum carboxy-terminal telopeptide (0.745 (0.23) to 0.382 (0.23) ng/mL) was significant (P<0.01). The change in the above parameters was comparable among the three groups after adjustment for age. CONCLUSIONS:Daily vitamin D supplementation with 600 IU to 2000 IU for 6 months results in Vitamin D sufficiency in >90% of pre-pubertal girls.
RCT Entities:
OBJECTIVE: To compare the adequacy and efficacy of different doses of vitamin D3 in pre-pubertal girls. DESIGN: Cluster Randomized controlled trial. SETTING: Public school in Delhi, India, between August 2015 and February 2016. PARTICIPANTS: 216 healthy pre-pubertal girls, aged 6.1-11.8 years. INTERVENTION: Daily supplementation with 600 IU (n=74), 1000 IU (n=67) or 2000 IU (n=75) of vitamin D3 under supervision for 6 months. OUTCOME MEASURES: Primary: Rise in serum 25 hydroxy Vitamin D (25(OH)D); Secondary: Change in bone formation and resorption markers. RESULTS: Following 6 months of supplementation, the mean (SD) rise in serum 25(OH)D was maximum with 2000 IU (24.09 (8.28) ng/mL), followed by with 1000 IU (17.96 (6.55) ng/mL) and 600 IU (15.48 (7.00) ng/mL). Serum 25(OH)D levels of ≥20 ng/mL were seen in 91% in 600 IU group , 97% in 1000 IU group and 100% in 2000 IU group. The overall mean (SD) rise in urinary calcium creatinine ratio (0.05 (0.28) to 0.13 (0.12) mg/mg), and serum procollagen type I N-terminal propeptide (538.9 (199.78) to 655.5 (218.24) ng/mL), and reduction in serum carboxy-terminal telopeptide (0.745 (0.23) to 0.382 (0.23) ng/mL) was significant (P<0.01). The change in the above parameters was comparable among the three groups after adjustment for age. CONCLUSIONS: Daily vitamin D supplementation with 600 IU to 2000 IU for 6 months results in Vitamin D sufficiency in >90% of pre-pubertal girls.