Efficacy of Chromium Picolinate in Reducing Acanthosis Nigricans Severity in Adolescents With Insulin Resistance

The goal of this clinical trial is to learn if chromium picolinate can reduce the severity of acanthosis nigricans and improve insulin resistance in adolescents with both conditions. It will also learn about the safety of chromium picolinate use in this age group. The main questions it aims to answer are:

1. Does chromium picolinate reduce the severity of acanthosis nigricans as measured by the Burke quantitative scale for acanthosis nigricans severity in adolescents with insulin resistance?
2. Does chromium picolinate improve insulin resistance as measured by the homeostasis model assessment of insulin resistance (HOMA-IR)?
3. What medical problems do participants have when taking chromium picolinate? Researchers will compare chromium picolinate to placebo to see if chromium picolinate is effective in reducing acanthosis nigricans severity and improving insulin resistance.

Participants will:

1. Take chromium picolinate or placebo daily for 24 weeks.
2. Acquire baseline assessment and then visit the clinic at 8 weeks, 16 weeks, and 24 weeks for clinical evaluation, acanthosis nigricans severity assessment using the Burke quantitative scale for acanthosis nigricans severity, laboratory assessment of insulin resistance using the homeostasis model assessment of insulin resistance, and monitoring for any side effects or complications.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Acanthosis Nigricans
• Intervention / Treatment: Drug: Chromium picolinate; Drug: Placebo matching Chromium Picolinate

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Iraq
  • Baghdad Governorate
    • Baghdad, Baghdad Governorate, Iraq, 10045
      • Baghdad Medical City / Children Welfare Teaching Hospital / Department of Endocrinology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adolescent patients of both sexes, aged 12 to 18 years.
• Clinically diagnosed with acanthosis nigricans.
• Present Insulin resistance, defined as Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) ≥ 2.5.
• Willing to participate in the study, with written informed consent provided by both the patient and guardian.

Exclusion Criteria:

• Diagnosis of type 1 or type 2 diabetes mellitus.
• Known hypersensitivity to chromium or any of the capsule excipients.
• Use of insulin-sensitizing medications (e.g., metformin, thiazolidinediones) within 3 months before screening.
• Use of systemic corticosteroids or other medications known to affect glucose metabolism within 3 months before screening.
• Significant renal disease (estimated glomerular filtration rate < 60 mL/min/1.73 m²) or liver disease (alanine aminotransferase or aspartate aminotransferase > 2.5 times the upper limit of normal).
• Pregnancy or lactation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chromium Picolinate; Participants in this arm (n=45) will recieve oral Chromium Picolinate 200mcg capsules once daily during the 24-weeks study period.	Drug: Chromium picolinate; Chromium Picolinate Cap. 200mcg once daily for 24-weeks.
Placebo Comparator: Placebo Control; Participants in this arm (n=45) will recieve oral placebo capsules matching the shape size and color of Chromium Picolinate, once daily during the 24-weeks study period; they will act as the control group.	Drug: Placebo matching Chromium Picolinate; An inert capsule identical in appearance and packaging to the chromium picolinate 200 microgram capsule (same size, shape, color, weight, and dosing schedule), manufactured without active ingredient. The capsule shell is composed of gelatin or hypromellose, matching the active capsules. The capsule is filled with inert excipients suitable for oral capsules, such as microcrystalline cellulose and magnesium stearate, to replicate the weight and flow properties of the active capsules. Optional coloring agents are included as needed to match the active product. Capsules are packaged in sealed blisters to minimize odor, taste, and visual cues. Dispensed by the investigational pharmacy according to the randomization schedule; to be taken once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the severity of insulin resistance	The severity of insulin resistance will be measured using the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR), this involves taking a fasting blood sample to measure plasma glucose and serum insulin and applying the formula (HOMA-IR = (Fasting insulin [µIU/mL] × Fasting glucose [mg/dL]) / 405). The primary outcome is the difference in insulin resistance severity based on HOMA-IR results between the chromium picolinate group and the placebo control group.	Baseline, 8 weeks, 16 weeks, 24 weeks
Change in the clinical severity of Acanthosis Nigricans	Acanthosis nigricans clinical severity will be measured using Burke's quantitative scale by a trained physician. This scale involves the summation of five parameters representing the severity of Acanthosis Nigricans, which are Neck severity (0-4), Neck texture (0-3), axilla severity (0-4), elbows (0 if Absent, 1 if present), knuckles (0 if Absent, 1 if present), and knees (0 if Absent, 1 if present). The minimum score of this scale is 0, and the maximum is 14. The primary outcome is the difference in acanthosis nigricans severity between the chromium picolinate group and the placebo control group.	Baseline, 8 weeks, 16 weeks, 24 weeks from enrollment

Collaborators and Investigators

• Sponsor: Uruk University
• Investigators: Principal Investigator: Ghasak Kais Abdulhussain, BSc, MSc, PhD (Pharmacology), Uruk University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Actual): January 1, 2026
• Study Completion (Actual): January 1, 2026

Study Registration Dates

• First Submitted: January 18, 2026
• First Submitted That Met QC Criteria: January 18, 2026
• First Posted (Actual): January 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Insulin resistance; Acanthosis Nigricans; Chromium Picolinate
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Skin Diseases; Hyperinsulinism; Pigmentation Disorders; Hyperpigmentation; Melanosis; Nutritional and Metabolic Diseases; Skin and Connective Tissue Diseases; Insulin Resistance; Acanthosis Nigricans; picolinic acid
• Other Study ID Numbers: UU-CR-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified participant-level data, including acanthosis nigricans severity measurements, insulin resistance severity status, baseline demographics, and follow-up data relevant to primary outcomes.
• IPD Sharing Time Frame: Upon publication of the trial result on open access repository.
• IPD Sharing Access Criteria: Access will be open to researchers and the public via a free, open-access data repository, with a DOI provided in the publication. Data will be de-identified to protect participant privacy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No