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Completed

NCT Number: NCT01170494

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

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.

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Key information

Conditions

Vitamin D Deficiency Avitaminosis Deficiency Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Faisal Specialist Hospital & research Center

Riyadh, 11211, Saudi Arabia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ergocalciferol 2000 IU orally, daily

Drug

ergocalciferol 2000 IU orally, daily

Other names: ergocalciferol

ergocalciferol 25000 IU oraly every 2 weeks

Drug

ergocalciferol 25000 IU oraly every 2 weeks

Other names: ergocalciferol

ergocalciferol 50000 IU orally every 4 weeks

Drug

ergocalciferol 50000 IU orally every 4 weeks

Other names: ergocalciferol

ergocal1000 IU & cholecal 1000 IU orally daily

Drug

ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day

Other names: ergocalciferol and cholecalciferol

cholecalciferol 2000 IU orally daily

Drug

cholecalciferol 2000 IU orally everyday

Other names: cholecalciferol

Cholecalciferol 25000 IU orally every 2 weeks

Drug

Cholecalciferol 25000 IU orally every 2 weeks

Other names: Cholecalciferol

Cholecalciferol 50000 orally every 4 weeks

Drug

Cholecalciferol 50000 orally every 4 weeks

Other names: Cholecalciferol

placebo orally everyday

Drug

placebo orally everyday

Other names: placebo

Primary outcomes

  1. area under the curve of 25 OH vitamin D level

    Time frame: 140 days

    area under the curve of total 25 OH vitamin D level from day 1 to 140

Secondary outcomes

  1. Cmax of 25 OH vitamin D

    Time frame: 140 days

    Cmax of total 25 OH vitamin D over the treatment period of 140 days

  2. Tmax of 25 OH vitamin D level

    Time frame: 140 days

    Tmax of total 25 OH vitamin D over the treatment period of 140 days

  3. area under the curve of vitamin D level

    Time frame: 140 days

    area under the curve of total vitamin D level over 140 days

  4. incidence of hypercalcemia

    Time frame: 140 days

  5. incidence of hypercalciuria

    Time frame: 140 days

Sponsors and collaborators

Lead sponsor

King Faisal Specialist Hospital & Research Center

Other

Registry information

Official study title

Effect of Vitamin D Oral Supplements on 25 OH Vitamin D Levels: A Randomized Controlled Trial

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jul 27, 2010
Registry last updated
Aug 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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