Vitamin D Supplementation in Younger Women

NCT00662844 | Completed DMC

• 2 other identifiers: PR065013DOD. CDMRP. W81XWH-07-1-0201
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

That on average it will require a vitamin D dose of 1700IU/day to increase the serum 25hydroxyvitamin D level from 20 to 30ng/ml in young Caucasian women and a dose of 1860 to 2480 IU/day in African American

Conditions

Hypovitaminosis D

Keywords

Vitamin D insufficiency,vitamin D3 treatment,young women

Outcome Measures

Primary Outcomes (2)

• Serum 25hydroxyvitamin D

  Baseline, Change from Baseline at 6 Months and 12 Months

• Parathyroid hormone

  Baseline, Change from Baseline at 6 Months and 12 Months

Secondary Outcomes (9)

• serum and urine calcium

  Baseline, Change from Baseline at 6 Months, 9 Months and 12 Months

• calcium absorption

  Baseline, Change from Baseline at 12 Months

• Bone density

  Baseline, Change from Baseline at 12 Months

• physical performance battery

  Baseline, Change from Baseline at 12 Months

• Forced Expiratory Volume FEV1

  Baseline, Change from Baseline at 12 Months

Study Arms (5)

A1 vitamin D3 400IU

PLACEBO COMPARATOR

Orally for one year

Dietary Supplement: vitamin D3

A2 vitamin D3 800IU

PLACEBO COMPARATOR

Orally for one year

Dietary Supplement: vitamin D3

A3 vitamin D3 1600IU

PLACEBO COMPARATOR

Orally for one year

Dietary Supplement: vitamin D3

A4 Vitamin D3 2400 IU

PLACEBO COMPARATOR

Orally for one year

Dietary Supplement: vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo for one year

Dietary Supplement: vitamin D3

Interventions

vitamin D3 DIETARY_SUPPLEMENT

Oral, one capsule daily of vitamin D3 (400IU, 800IU, 1600 IU, or 2400IU) plus calcium citrate (1-4 tablets) twice daily to reach a total calcium intake of 1000-1200 mg/day

Also known as: Calcium citrate (Citracal)

A1 vitamin D3 400IU; A2 vitamin D3 800IU; A3 vitamin D3 1600IU; A4 Vitamin D3 2400 IU; Placebo

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Premenopausal women, minimum age 25 years, maximum age 45 years. (Women with hysterectomy and/or oophorectomy must have a premenopausal FSH level.)
• Serum 25OHD level: 5 - 20 ng/ml
• BMI \< 45 kg/m2.
• Willing to discontinue vitamin D supplements after entering the study.
• Negative pregnancy test before BMD and calcium absorption tests.
• Willing to give signed informed consent form
• Subject is Caucasian or African American

You may not qualify if:

• Cancer (exceptions: basal cell carcinoma or if cancer occurred more than 10 years ago) or terminal illness.
• Previous hip fracture.
• Hemiplegia.
• Uncontrolled type I diabetes ± significant proteinuria or fasting blood sugar \>140 mg in type II diabetes.
• Kidney stones- \> 2 in a lifetime.
• Chronic renal failure (serum creatinine \>1.4 mg/dl).
• Evidence of chronic liver disease, including alcoholism.
• Physical conditions such as severe osteoarthritis, rheumatoid arthritis, heart failure severe enough to prevent reasonable physical activity.
• Previous treatment with bisphosphonates (more that 3 months), PTH or PTH derivatives, (e.g. Teriparatide) or Fluoride in the last 6 months.
• Previous treatment within the last 6 months with calcitonin or estrogen (except birth control pills).
• Chronic high dose corticosteroid therapy (\> 10 mg/day) for over 6 months and not within the last 6 months.
• Anticonvulsant therapy. (Dilantin, Phenobarbital)
• High dose thiazide therapy (\> 37.5 mg).
• hour urine calcium \> 290 mg on 2 baseline tests.
• Serum calcium exceeding upper normal limit on 2 baseline tests.

Sponsors & Collaborators

• Creighton University: lead
• University of Nebraska: collaborator

Related Publications (3)

• Gallagher JC, Kinyamu HK, Fowler SE, Dawson-Hughes B, Dalsky GP, Sherman SS. Calciotropic hormones and bone markers in the elderly. J Bone Miner Res. 1998 Mar;13(3):475-82. doi: 10.1359/jbmr.1998.13.3.475.

  PMID: 9525348 BACKGROUND

• Aloia JF, Talwar SA, Pollack S, Feuerman M, Yeh JK. Optimal vitamin D status and serum parathyroid hormone concentrations in African American women. Am J Clin Nutr. 2006 Sep;84(3):602-9. doi: 10.1093/ajcn/84.3.602.

  PMID: 16960175 BACKGROUND

• Holick MF, Siris ES, Binkley N, Beard MK, Khan A, Katzer JT, Petruschke RA, Chen E, de Papp AE. Prevalence of Vitamin D inadequacy among postmenopausal North American women receiving osteoporosis therapy. J Clin Endocrinol Metab. 2005 Jun;90(6):3215-24. doi: 10.1210/jc.2004-2364. Epub 2005 Mar 29.

  PMID: 15797954 BACKGROUND

MeSH Terms

Conditions

Vitamin D Deficiency

Interventions

Cholecalciferol; Calcium Citrate

Condition Hierarchy (Ancestors)

Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Calcium Compounds; Inorganic Chemicals; Citric Acid; Citrates; Tricarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• J C Gallagher, MD

  Creighton University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: April 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 25, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share