Vitamin D supplementation strategies for India. Ambrish Mithal MD, DM President Endocrine Society of India
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1 Vitamin D supplementation strategies for India Ambrish Mithal MD, DM President Endocrine Society of India
2 Global status
3 Vitamin D deficiency/ insufficiency is a big challenge globally more so in India!
4 What is the way out?? Is it sunlight? Is it food- natural or fortified? Is it supplementation?
5 Effect of UV light on serum 25(OH)D levels Highest individual serum 25(OH)D levels obtained from sunshine: 225 nmol/l
6 Vitamin D photosynthesis in Indians Indian pigmented skin is capable of making Vitamin D but requires longer exposure/ greater UV dose.. (Holick( Holick) Highest levels in unsupplemented adult Indians about 20 ng/ml (in security forces) Mean levels vary between 5 to 15 ng/ml.
7 Fortification??? Many issues.. Choice of vehicle How much will get in, will it be enough? Logistics of fortification, monitoring..
8 Vitamin D intake needed to achieve optimal 25 OH D level (Dawson Hughes et al, 2005) Increment inversely related to initial 25OHD level 40 IU (1 mcg) daily raises 25OHD by 1.2 nmol (or 0.5 ng/ml) if deficient 0.7 nmol (or 0.3ng/ml) if basal >70nmol Dose recommended 800 units /day Is it adequate for Indians???
9 Vitamin D intake to attain a desired serum 25(OH)D status Aloia et al, AJCN, 2008, month randomized double blind study- n=138 Dose adjustment every 2 months Target 75 nmol/l; ; max 220 nmol/l Dose required units/day!!
10 If the typical serum 25 (OH)D level in Indians is 10 ng/ml /ml And if the target serum 25 (OH)D level is 30 ng/ml /ml It would require about 2000 iu/day /day..
11 The usual calcium pill has 200 iu of vitamin D 2 pills a day equals 400 iu/day Grossly inadequate!! Studies underway with calcium pills containing 500 iu vit D (1000 iu/day)
12 Indian studies
13 Goswami et al, BJN, 2008
14 Supplemented with 60,000 IU weekly + 1 g elemental calcium daily for 8 weeks At 8 weeks. 22 of 23 subjects had 25(OH)D values 50 nmol/l At 1 year all subjects were vitamin D deficient Goswami et al, 2008
15 Effect of vitamin D supplementation in young Indian women units cholecalciferol/month IDEAL ACCEPTABLE Group A 4.85 Group B Baseline (Mar-Apr) After 3 Months (Jun-July)) Malhotra N,, Mithal A, Arch Osteoporosis 2009
16 Effect of vitamin D supplementation in young Indian women /month units cholecalciferol/month 25(OH)D ng/ml k/m Baseline Mar - Apr control 3months Jun- Jul Time 120k/m 60k/m 9months Nov-Dec IDEAL ACCEPTABLE Group A Group B Malhotra N, Mithal A, Arch Osteoporosis 2009
17 Change in PTH levels 60 Serum PTH pg/ml Group A Group B 0 Baseline Mar-Apr 3months Jun-Jul 9months Nov- Dec Time Malhotra N, Mithal A, Arch Osteoporosis 2009
18 DELHI SCHOOL GIRLS 6-17y (n=355) Enrollment (n=355) Excluded (n=65) Not meeting inclusion criteria Refused to participate A comparison of 2 regimens of Vitamin D supplementation Baseline data collected Anthropometric measurements; Biochemical estimation [Serum Ca, P, ALP, 25(OH) D, PTH] and dietary information. LSES (n=124) Randomized (n= 290) USES (n=166) o Baseline assessment in summer o Initiated supplementation in winter o 6 m re-assessment in summer o 1 year re-assessment in winter Two-monthly Vitamin D 3 60,000 IU (n=60) Lost to follow up (n = 0) One-monthly Vitamin D 3 60,000 IU (n=64) Follow- Up Two-monthly Vitamin D 3 60,000 IU (n=81) One-monthly Vitamin D 3 60,000 IU (n=85) Lost to follow up (n = 0) Indian Pediatrics, accepted Analyzed (n =124) Re-evaluation of biochemical parameters, after 6 and 12 months of supplementation with Vitamin D 3 Analyzed (n = 166)
19 Effect of Vitamin D supplementation on serum 25(OH)D (nmol/l) in LSES and USES subjects, at different time points LSES 0 (Summer) 6 months (S) 12 months (W)@ Mean diff between 2 monthly and 1 monthly groups statistically significant 2 monthly D ± ±2.01* 53.0 ±3.05 #,$ 1 monthly D3 2 monthly D3 1 monthly D ± ± ± ±1.5* 39.5±1.24* 46.8 ±1.45* 59.3 ±2.64 #,$ 38.2 ±2.13 # 49.9 ±2.01 # Maalouf et al, 2008: 14,000 IU weekly resulted in increase from 32 to 95 nmol/l * = P<0.05 for baseline vs. 6 month; # = P<0.05 for baseline vs. 12 month; $ = P<0.05 for 6 months vs. 12 month Indian Pediatrics, accepted
20 Effect of Vitamin D supplementation on serum 25(OH) D in LSES and USES subjects Indian Pediatrics, accepted LSES 60 USES Mean (SE) serum Vitamin D (nmol/l) Time (months) Mean (SE) serum Vitamin D values (nmol/l) Time (m onths) Tw o-monthly D3 group One-monthly D3 group Tw o-monthly D3 group One-monthly D3 group Baseline: 93.7 % school girls were vitamin D deficient [25 (OH) D < 50 nmol/l]. Despite supplementation with 60,000 IU of Vitamin D3 (monthly or two-monthly) only 67.8% LSES and 31.9% USES were vitamin D sufficient at the end of one year.
21 Supplementation - effect on maternal vitamin D, neonatal anthropometry and Ca Anthropometric indices: Differences persisted at 9 months Parameter Group A Group B Group C p Head circ (cm) 33.6 ± ± ± Length (cm) 49.4 ± ± ± Weight (kg) 2.8 ± ± ± Sahu et al, EJCN, 2009
22 Conclusions Starvation amidst plenty- abundant sunshine, low 25 OHD levels!! Can sunshine be enough for high risk groups?? Probably not!! Fortification??? More widespread advocacy of supplemenation??? Need about 2000 units/day in susceptible groups
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