A pilot randomized controlled trial of oral calcium and vitamin D supplementation using fortified laddoos in underprivileged Indian toddlers.
OBJECTIVE
Low habitual dietary calcium intake and vitamin D deficiency are common among Indian children. Using 'laddoo', an Indian snack, as a vehicle for administering calcium and vitamin D supplements, a randomized double-blind controlled trial was conducted for 12 months to assess its efficacy on total body less head (TBLH) bone mineral content (BMC) in underprivileged toddlers.


METHODS
A total of 60 toddlers (mean age 2.7±0.52 years, boys=31) were randomized to two groups, (i) study group receiving one calcium fortified laddoo (cereal-legume snack) containing 405 mg calcium per day and (ii) control receiving a non-fortified laddoo, containing 156 mg of indigenous calcium. Both groups also received a laddoo fortified with 30,000 IU of vitamin D(3) per month. Outcome measures included TBLH bone area (BA) and TBLH BMC by GE-Lunar DPX Pro Pencil Beam Dual-Energy X-ray absorptiometry.


RESULTS
At baseline, mean energy, protein and calcium intakes were 71, 72 and 47% of Indian Recommended Dietary allowances. In all, 87 and 83% toddlers were hypocalcaemia and vitamin D deficient, respectively. Mean TBLH BMC was 289.5±45.8 g. Post supplementation, mean TBLH BMC of study group showed a significantly greater (P<0.01) increase of 35% as against 28% in controls and the difference remained significant after adjusting for vitamin D status, calcium intake, height and TBLH BA.


CONCLUSIONS
Daily supplementation with calcium fortified laddoo, and monthly vitamin D supplement resulted in a significant increase in TBLH BMC of underprivileged toddlers. We believe that such strategies have the potential of addressing nutritional problems in developing countries.
Growth and Endocrine Unit, HCJMRI, Jehangir Hospital, Pune, India.
V H
VH
Ekbote
A V
AV
Khadilkar
S A
SA
Chiplonkar
N M
NM
Hanumante
V V
VV
Khadilkar
M Z
MZ
Mughal
D015502:Absorptiometry, Photon; D000284:Administration, Oral; D015519:Bone Density / Q000187:drug effects; D002118:Calcium / Q000008:administration & dosage* / Q000172:deficiency*; D002675:Child, Preschool; D002762:Cholecalciferol / Q000008:administration & dosage*; D002947:Cities; D003906:Developing Countries; D004032:Diet; D004311:Double-Blind Method; D005260:Female; D005527:Food, Fortified; D006801:Humans; D007194:India; D008297:Male; D010865:Pilot Projects; D011203:Poverty; D014808:Vitamin D Deficiency / Q000178:diet therapy*
D002762:Cholecalciferol; D002118:Calcium