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. 2020 May 18;16(2):e1085. doi: 10.1002/cl2.1085
Methods Design: RCT
Unit of randomisation: Individually randomised trial
Participants Location/Setting: State run school in Pune, India
Sample size: 50 adolescent girls
Dropouts/withdrawals: 1 out of 50 loss to follow‐up
Sex: Only adolescent post menarchal girls
Mean age: 14.6 years
Inclusion criteria: Post Menarche adolescent girls
Exclusion criteria: Not specified
Interventions Intervention (sample size):
Group 1 (N = 25): Subjects in the treatment group were administered 6 vitamin D2 (Ergocalciferol; Celltech, UK) tablets each containing 1.25 mg
(50,000 IU) orally at 1, 4, 7 and 10 months
Control (sample size):
Group 2 (N = 25): Placebo group the local pharmacist prepared tablets which were identical in number, colour, size and texture to the ergocalciferol, but contained only sucrose
The intervention was provided for a duration of one year and all participants received 250 mg elemental calcium (calcium carbonate) daily
Outcomes Primary outcomes: Total body bone mineral content, Lumbar spine bone mineral content and lumbar spine bone mineral apparent density
Secondary outcomes: Total body lean, fat mass and serum concentrations of biochemical parameters
Timing of outcome assessment: After one year of intervention
Notes Study start date: February 2006
Study end date: April 2007
Funding source: Not specified
Conflicts of interest: None declared