None listed
Conditions
Brief summary
The incidence of childhood rickets is increasing and is caused by vitamin D deficiency. Of those children, 81% of their mothers are also deficient. We aim to screen high risk women in early pregnancy and randomise those found deficient to either treatment with vitamin D supplements or non-treatment. We will monitor the effect of vitamin D supplementation by repeating vitamin D concentrations during pregnancy, cord and maternal blood at birth, and infant and maternal blood at six weeks postnatally. We hope to develop a protocol so all high risk women will be identified and treated, thereby preventing paediatric complications.
Interventions
The treatment arm will be given 2000 international units (IU) of cholecalciferol orally daily commencing between 14 and 18 weeks gestation. Vitamin D levels will be checked again at 28 weeks gestation. If still deficient the dose will be doubled to 4000IU orally daily until birth. Follow up will cease at six weeks postnatally but vitamin D supplements will need to be taken indefinitely.
Sponsors
Jodie Benson
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
At risk women - dark skinned - veiled Anyone with vitamin D deficiency that has not commenced treatment prior to recruitment.
Exclusion criteria
Women taking barbituates or anticonvulsants (decreased vitamin D absorption). Women with severe renal failure.
Outcome results
None listed