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Completed

NCT Number: NCT00784511

Vitamin D, Glucose Control and Insulin Sensitivity in African-Americans

North American blacks tend to have low blood levels of vitamin D because pigmentation blocks vitamin D production in the skin. They also have higher rates of developing type 2 diabetes and higher rates of complications from the disease compared with whites. Although there is compelling evidence that adequate vitamin D may reduce the risk for type 2 diabetes in whites, recent evidence from a national survey demonstrated an association of vitamin D with diabetes in whites but not in blacks. However, the central hypothesis of this study is that providing enough supplemental vitamin D to blacks (raising their blood levels higher than that of most participants in the survey) will improve blood measures related to diabetes risk. The proposed study is a 12-week randomized, double-blind, placebo-controlled experiment designed to examine the effect of vitamin D supplementation (100 μg/d ) on insulin secretion, insulin sensitivity and glucose control in pre-diabetic black men and women aged 40 and older.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • African-American by self designation
  • Glucose intolerance defined as FPG ≥ 100 mg/dl or A1c ≥ 5.8%
  • BMI 25.0-39.9
  • Age 40 or older

Exclusion criteria

Medical Conditions

  • Diabetes potentially requiring pharmacotherapy, defined as A1c > 7%
  • Uncontrolled thyroid disease
  • Current parathyroid, liver or kidney disease
  • Renal stone within 5 years
  • Sarcoidosis, current pancreatitis, active tuberculosis, hemiplegia, gout
  • Inflammatory bowel disease, colostomy, malabsorption
  • Cancer other than basal cell skin cancer within 5 years
  • Uncontrolled arrhythmia in past year
  • Albinism or other condition associated with reduced skin pigmentation
  • Pregnancy over the last 1 year
  • Intent to become pregnant
  • Menopause onset within 1 year
  • Any other unstable medical condition Laboratory Tests
  • Fasting plasma glucose < 100
  • Hemoglobin A1c > 7%
  • Laboratory evidence of liver disease (e.g. AST > 70 U/L or ALT > 72 IU/L)
  • Laboratory evidence of kidney disease (e.g. estimated glomerular filtration rate < 60 ml/min/1.73 m2).
  • Elevated spot urine calcium to creatinine ratio > 0.38 mg/dl*
  • Abnormal serum calcium (serum calcium > 10.5 mg/dl)
  • Anemia (Hematocrit < 36% in men, <33% in women) Medications (use in past three months)
  • Estrogen or testosterone
  • Prescription vitamin D
  • Lithium
  • Oral corticosteroids
  • Anti-seizure medications
  • Unstable doses of psychotropics or phenothiazines
  • Cholestyramine Supplements (current use - may discontinue after screening)
  • Vitamin D supplements, cod liver oil, calcium supplements Other
  • Body mass index less <25 or > 39.9
  • Consumption of more than 14 alcoholic drinks per week
  • Inability to attend all three study visits as scheduled
  • Inability to provide written informed consent
  • age < 40 years
  • not African-American (by self-designation)
  • Participation in another research intervention study
  • corresponds to a 24-hour urinary calcium excretion > 400 mg

Treatment and study plan

Cholecalciferol

Dietary Supplement

4000 IU/d

Other names: vitamin D3, vitamin D

Microcrystalline Cellulose

Other

1/d

Other names: placebo

Primary outcomes

  1. Insulin secretion rate

    Time frame: 12 weeks

  2. Insulin sensitivity index

    Time frame: 12 weeks

  3. 2-hr post load glucose

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2008
Registry last updated
Nov 14, 2014

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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