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Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels

K

King Faisal Specialist Hospital & Research Center

Status

Completed

Conditions

Vitamin D Deficiency

Treatments

Drug: ergocalciferol 25000 IU oraly every 2 weeks
Drug: ergocal1000 IU & cholecal 1000 IU orally daily
Drug: placebo orally everyday
Drug: ergocalciferol 2000 IU orally, daily
Drug: cholecalciferol 2000 IU orally daily
Drug: Cholecalciferol 50000 orally every 4 weeks
Drug: ergocalciferol 50000 IU orally every 4 weeks
Drug: Cholecalciferol 25000 IU orally every 2 weeks

Study type

Interventional

Funder types

Other

Identifiers

NCT01170494
RAC 2101041

Details and patient eligibility

About

Vitamin D deficiency is common world wide. 25 OH vitamin D level is the best indicator of vitamin D status. Vitamin D supplements are available as vitamin D2 or D3, in small daily or large weekly/monthly doses. Controversy continues on the relative potency of vitamin D2 compared to D3 and of daily compared to weekly or monthly doses, in increasing/maintaining total 25 OH vitamin D level.

The investigators plan to conduct a controlled trial to compare the effect of various vitamin D supplements on 25 OH vitamin D levels in healthy adults with starting 25 OH vitamin D level between 20 to 50 nmol/L.

Enrollment

279 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Healthy adults living in Riyadh area who consume no more than one serving of milk/day, do not take vitamin supplement, habitually have less than 10 hr of sun exposure per week, don't suffer from granulomatous conditions, liver disease, or kidney disease, and don't take anticonvulsants, barbiturates, or steroids.
  • 25 OH vitamin D level between 20 to 50 nmol/L.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

279 participants in 8 patient groups, including a placebo group

D2 2000 IU daily
Active Comparator group
Treatment:
Drug: ergocalciferol 2000 IU orally, daily
D3 2000 IU daily
Active Comparator group
Treatment:
Drug: cholecalciferol 2000 IU orally daily
D2 1000 IU + D3 1000 IU daily
Active Comparator group
Treatment:
Drug: ergocal1000 IU & cholecal 1000 IU orally daily
D2 25000 IU Q2wk
Active Comparator group
Treatment:
Drug: ergocalciferol 25000 IU oraly every 2 weeks
D3 25000 IU Q2wk
Active Comparator group
Treatment:
Drug: Cholecalciferol 25000 IU orally every 2 weeks
D2 50000 IU Q4wk
Active Comparator group
Treatment:
Drug: ergocalciferol 50000 IU orally every 4 weeks
D3 50000 IU Q4wk
Active Comparator group
Treatment:
Drug: Cholecalciferol 50000 orally every 4 weeks
placebo daily
Placebo Comparator group
Treatment:
Drug: placebo orally everyday

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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